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Guideline Summary
Guideline Title
Late intrauterine fetal death and stillbirth.
Bibliographic Source(s)
Royal College of Obstetricians and Gynaecologists (RCOG). Late intrauterine fetal death and stillbirth. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2010 Oct. 33 p. (Green-top guideline; no. 55).  [176 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Late intrauterine fetal death (IUFD) and stillbirth

Note: This guideline does not include the management of multiple pregnancies with a surviving fetus, stillbirth following late fetocide, late delivery of fetus papyraceous or the management of specific medical conditions associated with increased risk of late IUFD. Recommendations about the psychological aspects of late IUFD are focused on the main principles of care to provide a framework of practice for maternity clinicians.

Guideline Category
Counseling
Diagnosis
Evaluation
Management
Clinical Specialty
Family Practice
Internal Medicine
Obstetrics and Gynecology
Pathology
Psychology
Intended Users
Advanced Practice Nurses
Nurses
Patients
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Social Workers
Guideline Objective(s)
  • To identify evidence-based options for women (and their relatives) who have a late intrauterine fetal death (IUFD: after 24 completed weeks of pregnancy) of a singleton fetus
  • To incorporate information on general care before, during and after birth, and care in future pregnancies
Target Population

Women (and their relatives) who have a late intrauterine fetal death (IUFD: after 24 completed weeks of pregnancy) of a singleton fetus

Interventions and Practices Considered

Diagnosis/Assessment

  1. Real-time ultrasonography
  2. Clinical assessment and laboratory tests for maternal wellbeing, cause of death, and future pregnancy planning
  3. Use of tests/systems to categorise late intrauterine fetal death (IUFD) and stillbirth
  4. Kleihauer test, if rhesus-D (RhD)-negative, with anti-RhD gammaglobulin administration
  5. Determination of baby's blood group from baby or cord or using free fetal deoxyribonucleic acid (ffDNA)
  6. Appropriate precautions when sexing baby including parent education regarding potential difficulty, using two experienced healthcare practitioners, and rapid karyotyping using quantitative fluorescent polymerase chain reaction (QF-PCR) or fluorescence in situ hybridisation (FISH)
  7. Cytogenetic analysis
  8. Perinatal postmortem examination

Management

  1. Discussion and written information to support parental choice about care
  2. Considerations for timing and mode of labor and birth
  3. Labor induction with mifepristone and a prostaglandin and mechanical methods (in the context of a clinical trial only)
  4. Intravenous broad-spectrum antibiotic therapy for women with sepsis
  5. Pain relief including diamorphine and regional anaesthesia
  6. Monitoring for scar rupture in women undergoing vaginal birth after caesarean (VBAC)
  7. Oxytocin augmentation for VBAC, if needed
  8. Dopamine agonists for lactation suppression
  9. Use of counseling, debriefing services, support groups, and bereavement officers
  10. Support for seeing, holding, naming, and mementos as desired by parents
  11. Parent education regarding fertility and contraception
  12. Patient follow-up
  13. Patient management during subsequent pregnancy

Note: Auscultation and cardiotocography were considered but not recommended for investigation of suspected IUFD. Estrogens were considered but not recommended for suppression of lactation.

Major Outcomes Considered
  • Accuracy of diagnostic tests
  • Accuracy of identification of the cause of late intrauterine fetal death (IUFD) and stillbirth
  • Maternal morbidity

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

This Royal College of Obstetricians and Gynaecologists (RCOG) guideline was developed in accordance with standard methodology for producing RCOG Green-top guidelines (see "Availability of Companion Documents" field). A search was performed in the OVID database, which included Medline, EMBASE, the Cochrane Database of Systematic Reviews, the Cochrane Control Register of Controlled Trials (CENTRAL), the Database of Abstracts of Reviews and Effects (DARE) and the American College of Physicians (ACP) Journal Club. The National Guideline Clearinghouse, Sands publications, Confidential Enquiry into Maternal and Child Health (CEMACH) reports, ISI Web, the Cochrane Methodology Register, the TRIP (Turning Research into Practice) database and Evidence-Based Medicine (EBM) Reviews – including Health Technology Assessment and the National Health Service (NHS) Economic Evaluation Database – were also searched. Search terms included 'stillbirth, intrauterine', 'fetal death, intrauterine', 'lactation suppression', 'induction of labour and intrauterine fetal death', 'intrauterine death' and 'intrauterine death and diagnosis'. The search was limited to 1 January 1980 to 5 June 2008 and to humans after 24 completed weeks of pregnancy. Duplicates were removed and filtered on Reference Manager for systematic reviews, randomised controlled trials, cohort studies, case–control studies and reviews. Six hundred and forty-nine manuscripts were obtained. Further documents were obtained by the use of free text terms and hand searches. The search was updated in June 2010 for vaginal birth after caesarean (VBAC) and induction of labour.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Classification of Evidence Levels

1++ High-quality meta-analyses, systematic review of randomised controlled trials or randomised controlled trials with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a low risk of bias

1- Meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a high risk of bias

2++ High-quality systematic reviews of case–control or cohort studies or high quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal

2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal

2- Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal

3 Non-analytical studies, e.g., case reports, case series

4 Expert opinion

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Reviewing and Grading of Evidence

Once the evidence has been collated for each clinical question it needs to be appraised and reviewed (refer to section 3 in "Development of RCOG Green-top guidelines: producing a clinical practice guideline" for information on the formulation of the clinical questions; see the "Availability of Companion Documents" field). For each question, the study type with least chance of bias should be used. If available, randomised controlled trials (RCTs) of suitable size and quality should be used in preference to observational data. This may vary depending on the outcome being examined.

The level of evidence and the grade of the recommendations used in this guideline originate from the guidance by the Scottish Intercollegiate Guidelines Network (SIGN) Grading Review Group, which incorporates formal assessment of the methodological quality, quantity, consistency, and applicability of the evidence base. The methods used to appraise individual study types are available from the SIGN Web site (www.sign.ac.uk/methodology/checklists.html External Web Site Policy). An objective appraisal of study quality is essential, but paired reviewing by guideline leads may be impractical because of resource constraints.

Once evidence has been collated and appraised, it can be graded. A judgement on the quality of the evidence will be necessary using the grading system (see the "Rating Scheme for the Strength of the Evidence" field). Where evidence is felt to warrant 'down-grading', for whatever reason, the rationale must be stated. Evidence judged to be of poor quality can be excluded. Any study with a high chance of bias (either 1– or 2–) will be excluded from the guideline and recommendations will not be based on this evidence. This prevents recommendations being based on poor-quality RCTs when higher-quality observational evidence is available.

Methods Used to Formulate the Recommendations
Expert Consensus
Informal Consensus
Description of Methods Used to Formulate the Recommendations

Guideline Development

The development of guidelines involves more than the collation and reviewing of evidence. Even with high-quality data from systematic reviews of randomised controlled trials, a value judgement is needed when comparing one therapy with another. This will therefore introduce the need for consensus.

Royal College of Obstetricians and Gynaecologists (RCOG) Green-top guidelines are drafted by nominated developers, in contrast to other guideline groups such as the National Institute for Health and Clinical Excellence (NICE) and the Scottish Intercollegiate Guidelines Network (SIGN), who use larger guideline development groups. Equally, in contrast to other guideline groups, the topics chosen for development as Green-top guidelines are concise enough to allow development by a smaller group of individuals.

In agreeing the precise wording of evidence-based guideline recommendations and in developing consensus-based 'good practice points', the Guidelines Committee (GC) will employ an informal consensus approach through group discussion. In line with current methodologies, the entire development process will follow strict guidance and be both transparent and robust. The RCOG acknowledges that formal consensus methods have been described but these require further evaluation in the context of clinical guideline development. It is envisaged that this will not detract from the rigor of the process but prevent undue delays in development.

Rating Scheme for the Strength of the Recommendations

Grades of Recommendation

A - At least one meta-analysis, systematic review or randomised controlled trial rated as 1++ and directly applicable to the target population; or

A systematic review of randomised controlled trials or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results

B - A body of evidence including studies rated as 2++ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C - A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D - Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Point - Recommended best practice based on the clinical experience of the guideline development group

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Following discussion in the Guidelines Committee (GC), each Green-top guideline is formally peer reviewed. At the same time, the draft guideline is published on the Royal College of Obstetricians and Gynaecologists (RCOG) Web site for further peer discussion before final publication.

All comments will be collated by the RCOG and tabulated for consideration by the guideline leads. Each comment will require discussion. Where comments are rejected then justification will need to be made. Following this review, the document will be updated and the GC will then review the revised draft and the table of comments.

Once the GC signs-off on the guideline, it is submitted to the Standards Board for approval before final publication.

Recommendations

Major Recommendations

In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.

Classification of evidence levels (1++ to 4) and grades of recommendations (A–D) are defined at the end of the "Major Recommendations" field.

Diagnosis

What Is the Optimal Method for Diagnosing Late Intrauterine Fetal Death (IUFD)?

D - Auscultation and cardiotocography should not be used to investigate suspected IUFD.

D - Real-time ultrasonography is essential for the accurate diagnosis of IUFD.

What Is the Best Practice for Discussing the Diagnosis and Subsequent Care?

B - Discussions should aim to support maternal/parental choice.

D - Parents should be offered written information to supplement discussions.

Many strategies have been described for discussing bad news. Late IUFD poses particular difficulties as it is often sudden and unexpected. A crucial component is to determine the emotional feelings and needs of the mother and her companions. This empathetic approach seeks to identify and understand women's thoughts and wishes but without trying to shape them. Women with an IUFD and their partners value acceptance and recognition of their emotions highly. [Evidence level 3]

The developers concluded that carers should neither persuade parents nor make assumptions that would limit parental choice. Initial discussions can be used to emphasise choice in decision making. [Evidence level 2]

Investigation of the Cause of Late IUFD

What Are the General Principles of Investigation?

D - Clinical assessment and laboratory tests should be recommended to assess maternal wellbeing (including coagulopathy) and to determine the cause of death, the chance of recurrence and possible means of avoiding further pregnancy complications.

C - Parents should be advised that no specific cause is found in almost half of stillbirths.

B - Systems that use customised weight charts and capture multiple contributing factors should be used to categorise late IUFDs.

An important purpose of investigation is to assess maternal wellbeing and ensure prompt management of any potentially life-threatening maternal disease. This includes a detailed history of events during pregnancy and clinical examination for pre-eclampsia, chorioamnionitis and placental abruption. There is also a moderate risk of maternal disseminated intravascular coagulation (DIC): 10% within 4 weeks after the date of late IUFD, rising to 30% thereafter. This can be tested for by clotting studies, blood platelet count and fibrinogen measurement. [Evidence level 3]

Are There Any Special Recommendations for Women with an IUFD Who Are Rhesus D (RhD)-Negative?

C - Women who are RhD-negative should be advised to have a Kleihauer test undertaken urgently to detect large feto–maternal haemorrhage (FMH) that might have occurred a few days earlier. Anti-RhD gammaglobulin should be administered as soon as possible after presentation.

C - If there has been a large FMH, the dose of anti-RhD gammaglobulin should be adjusted upwards and the Kleihauer test should be repeated at 48 hours to ensure the fetal red cells have cleared.

D - It is important to know the baby's blood group; if no blood sample can be obtained from the baby or cord, RhD typing should be undertaken using free fetal DNA (ffDNA) from maternal blood taken shortly after birth.

What Tests Should Be Recommended to Identify the Cause of Late IUFD?

A - Tests should be directed to identify scientifically proven causes of late IUFD.

Commonly associated antepartum conditions include congenital malformation, congenital fetal infection, antepartum haemorrhage, pre-eclampsia and maternal disease such as diabetes mellitus. The common causes of intrapartum death include placental abruption, maternal and fetal infection, cord prolapse, idiopathic hypoxia–acidosis and uterine rupture. [Evidence level 3]

Transplacental infections associated with IUFD include cytomegalovirus [Evidence level 2+], syphilis [Evidence level 1+] and parvovirus B19 [Evidence level 2++] as well as listeria [Evidence level 2+], rubella [Evidence level 3], toxoplasmosis [Evidence level 2+], herpes simplex [Evidence level 2+], coxsackievirus, leptospira, Q fever, and Lyme disease. Malaria parasitaemia has also been associated with stillbirth (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.3–4.1) [Evidence level 2++].

Ascending infection, with or without membrane rupture, with Escherichia coli, Klebsiella, Group B Streptococcus, Enterococcus, mycoplasma/ureaplasma, Haemophilus influenzae and Chlamydia are the more common infectious causes in developed countries. Other infections are either historical causes or common only in developing countries. [Evidence level 2+]

Table 1 in the original guideline document summarises the diagnostic tests available, their indications and value and the evidence to support their use.

What Precautions Should Be Taken When Sexing the Baby?

B - If there is any difficulty or doubt, rapid karyotyping should be offered using quantitative fluorescent polymerase chain reaction (QF-PCR) or fluorescence in situ hybridisation (FISH).

What Is Best Practice Guidance for Cytogenetic Analysis of the Baby?

D - Samples from multiple tissues should be used to increase the chance of culture.

D - More than one cytogenetic technique should be available to maximise the chance of informative results.

D - Culture fluid should be stored in a refrigerator and thawed thoroughly before use.

Karyotyping is important as about 6% of stillborn babies will have a chromosomal abnormality. [Evidence level 3]

Some abnormalities are potentially recurrent and can be tested for in future pregnancies. Culture potentially provides the greatest range of genetic information (trisomies, monosomies, translocations, major deletions and marker chromosomes). Microdeletions have to be requested specifically, usually according to the result of any postmortem examination. If all cultures fail, QF-PCR can be performed on extracted DNA. [Evidence level 2+ extrapolated]

Many laboratories are moving towards DNA-based methods for routine chromosome analysis, avoiding the need for cell culture. It is a reliable (<0.01% failure rate), efficient and cheap technique for detecting common aneuploidies. It provides slightly less detailed limited genetic information and is unreliable for the detection of translocations and marker chromosomes. [Evidence level 2++ extrapolated]

A range of tissue types can be used (see below), but all cell cultures can fail. [Evidence level 3]

Contamination with bacteria is an avoidable reason for failure to obtain results. [Evidence level 2++ extrapolated]

Culture fluid containing antibiotics can reduce this risk. Perinatal specimens suitable for karyotyping include skin, cartilage and placenta. Skin specimens are associated with a higher rate of culture failure (~60%), twice that of other tissues, including placenta. Placenta usually has the advantages of being the most viable tissue and of more rapid cell culture, but the disadvantages of maternal contamination and placental pseudomosaicism. The next best is cartilage, e.g., patella, but cartilage is harder to sample. Amniocentesis can also provide cytogenetic results if the mother chooses expectant management, but patient acceptability and safety (infection) of amniocentesis has not been investigated in this setting. [Evidence level 3]

Placental biopsy (approximately 1 cm diameter) should be taken from the fetal surface close to the cord insertion (to avoid tissue of maternal origin). Skin biopsy should be deep to include underlying muscle (about 1 cm in length from the upper fleshy part of the thigh). The skin can be closed with wound adhesive strips and tissue adhesives, but this is less successful when the baby is severely macerated.

What Is the Guidance on Perinatal Postmortem Examination for Maternity Clinicians?

C - Parents should be offered full postmortem examination to help explain the cause of an IUFD.

C - Parents should be advised that postmortem examination provides more information than other (less invasive) tests and this can sometimes be crucial to the management of future pregnancy.

D - Written consent must be obtained for any invasive procedure on the baby including tissues taken for genetic analysis. Consent should be sought or directly supervised by an obstetrician or midwife trained in special consent issues and the nature of perinatal postmortem, including retention of any tissues for clinical investigation, research and teaching.

D - Pathological examination of the cord, membranes and placenta should be recommended whether or not postmortem examination of the baby is requested.

D - The examination should be undertaken by a specialist perinatal pathologist.

D - Less invasive methods such as needle biopsies can be offered, but these are much less informative and reliable than conventional postmortem.

D - Ultrasound and magnetic resonance imaging (MRI) should not yet be offered as a substitute for conventional postmortem.

D - Magnetic resonance imaging can be a useful adjunct to conventional postmortem.

Labour and Birth

What Are the Recommendations for Timing and Mode of Birth?

C - Recommendations about labour and birth should take into account the mother's preferences as well as her medical condition and previous intrapartum history.

D - Women should be strongly advised to take immediate steps towards delivery if there is sepsis, pre-eclampsia, placental abruption or membrane rupture, but a more flexible approach can be discussed if these factors are not present.

D - Well women with intact membranes and no laboratory evidence of disseminated intravascular coagulation (DIC) should be advised that they are unlikely to come to physical harm if they delay labour for a short period, but they may develop severe medical complications and suffer greater anxiety with prolonged intervals. Women who delay labour for periods longer than 48 hours should be advised to have testing for disseminated intravascular coagulation twice weekly (see Table 1 in the original guideline document).

D - Women contemplating prolonged expectant management should be advised that the value of postmortem may be reduced.

How Should Labour Be Induced for a Woman with an Unscarred Uterus?

D - A combination of mifepristone and a prostaglandin preparation should usually be recommended as the first-line intervention for induction of labour.

B - Misoprostol can be used in preference to prostaglandin E2 because of equivalent safety and efficacy with lower cost but at doses not currently marketed in the United Kingdom (UK).

A - Women should be advised that vaginal misoprostol is as effective as oral therapy but associated with fewer adverse effects.

What Is Best Practice for Induction of Labour for a Woman with a History of Lower Segment Caesarean Section (LSCS)?

D - A discussion of the safety and benefits of induction of labour should be undertaken by a consultant obstetrician.

A - Mifepristone can be used alone to increase the chance of labour significantly within 72 hours (avoiding the use of prostaglandin).

A - Mechanical methods for induction of labour in women with an IUFD should be used only in the context of a clinical trial.

C - Women with a single lower segment scar should be advised that, in general, induction of labour with prostaglandin is safe but not without risk.

C - Misoprostol can be safely used for induction of labour in women with a single previous LSCS and an IUFD but with doses not yet marketed in the UK.

C - Women with two previous LSCS should be advised that in general the absolute risk of induction of labour with prostaglandin is only a little higher than for women with a single previous LSCS.

D - Women with more than two LSCS deliveries or atypical scars should be advised that the safety of induction of labour is unknown.

What Are the Recommendations for Intrapartum Antimicrobial Therapy?

C - Women with sepsis should be treated with intravenous broad-spectrum antibiotic therapy (including antichlamydial agents).

Are There Any Special Recommendations for Pain Relief in Labour?

D - Diamorphine should be used in preference to pethidine.

D - Regional anaesthesia should be available for women with an IUFD.

D - Assessment for DIC and sepsis should be undertaken before administering regional anaesthesia.

What Are the Recommendations for Women Labouring with a Scarred Uterus?

D - Women undergoing vaginal birth after caesarean (VBAC) should be closely monitored for features of scar rupture.

B - Oxytocin augmentation can be used for vaginal birth after caesarean, but the decision should be made by a consultant obstetrician.

Puerperium

What Are the Options for Suppression of Lactation?

A - Women should be advised that almost one-third of those that choose nonpharmacological measures are troubled by excessive discomfort.

A - Women should be advised that dopamine agonists successfully suppress lactation in a very high proportion of women and are well tolerated by a very large majority; cabergoline is superior to bromocriptine.

D - Dopamine agonists should not be given to women with hypertension or pre-eclampsia.

D - Estrogens should not be used to suppress lactation.

Psychological and Social Aspects of Care

What Psychological Problems Can Follow Late IUFD?

B - Carers must be alert to the fact that mothers, partners and children are all at risk of prolonged severe psychological reactions including post-traumatic stress disorder but that their reactions might be very different.

What Is Best Practice for Use of Interventions That Might Aid Psychological Recovery?

D - Carers should be aware of and responsive to possible variations in individual and cultural approaches to death.

A - Counselling should be offered to all women and their partners.

D - Other family members, especially existing children and grandparents, should also be considered for counselling.

A - Debriefing services must not care for women with symptoms of psychiatric disease in isolation.

D - Parents should be advised about support groups.

D - Bereavement officers should be appointed to coordinate services.

What Is the Evidence for Seeing, Holding, Naming and Mementos?

C - Carers should avoid persuading parents to have contact with their stillborn baby, but should strongly support such desires when expressed.

C - Parents should be offered, but not persuaded, to retain artefacts of remembrance.

C - Maternity units should have the facilities for producing photographs, palm and foot prints and locks of hair with presentation frames.

What Are the Recommendations for Spiritual Guidance, Burial, Cremation and Remembrance?

C - The legal responsibility for the child's body rests with the parents but can be delegated to hospital services.

C - Parents should be allowed to choose freely about attendance at a funeral service.

What Advice Should Be Given about Fertility?

C - Information about fertility and contraception should be offered to mothers before returning home.

Follow-up

What Are the Recommendations for the Content of the Follow-up Appointment?

C - Women should be offered general prepregnancy advice, including support for smoking cessation.

B - Women should be advised to avoid weight gain if they are already overweight (body mass index over 25) and to consider weight loss.

C - An offer should be made to discuss the potential benefit of delaying conception until severe psychological issues have been resolved.

A - Carers should be aware that while mothers tend to experience greater anxiety when conception occurs soon after a fetal loss, partners are more likely to suffer anxiety if conception is delayed.

B - Parents can be advised that the absolute chance of adverse events with a pregnancy interval less than 6 months remains low and is unlikely to be significantly increased compared with conceiving later.

Women might wish to keep a written log of questions and comments. Some women/couples might wish to use this to help set the agenda themselves at the start of the meeting. As well as an opportunity to ask about the physical and emotional wellbeing of the mother and her partner, the meeting allows parents time to discuss the results of tests and the likely cause of late IUFD. The meeting can also focus on the prognosis and options for future pregnancies. The discussion should cover general preparation for pregnancy: lifestyle, folic acid supplementation and rubella vaccination. Parents often desire an open, honest discussion with an opportunity to make comments and the chance to raise any concerns they might have. If care has been suboptimal, parents might want this to be acknowledged, lessons to be learned and care in the future to be improved.

Pregnancy Following Unexplained Stillbirth

What Recommendations Should Be Made for Pregnancy Following Unexplained Late IUFD?

B - Women with a previous unexplained IUFD should be recommended to have obstetric antenatal care.

What Recommendations Should Be Made for Maternal Care after the Next Birth?

C - Carers should be vigilant for postpartum depression in women with a previous IUFD.

C - Carers should be aware that maternal bonding can be adversely affected.

Definitions:

Grades of Recommendation

A - At least one meta-analysis, systematic review or randomised controlled trial rated as 1++ and directly applicable to the target population; or

A systematic review of randomised controlled trials or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results

B - A body of evidence including studies rated as 2++ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C - A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D - Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Point - Recommended best practice based on the clinical experience of the guideline development group.

Classification of Evidence Levels

1++ High-quality meta-analyses, systematic review of randomised controlled trials or randomised controlled trials with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a low risk of bias

1- Meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a high risk of bias

2++ High-quality systematic reviews of case–control or cohort studies or high quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal

2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal

2- Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal

3 Non-analytical studies; e.g., case reports, case series

4 Expert opinion

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Identification of the cause of late intrauterine fetal death (IUFD) and stillbirth
  • Accurate assessment of maternal wellbeing and prompt management of any potentially life-threatening maternal disease
  • Provision of appropriate care before, during and after birth, and care in future pregnancies
  • Provision of appropriate psychosocial support to parents and their relatives and friends
Potential Harms
  • In two randomised controlled trials that compared oral and vaginal misoprostol, the systemic adverse effects (diarrhoea, vomiting, shivering and pyrexia) were more common with oral misoprostol.
  • Mechanical methods of induction might increase the risk of ascending infection in the presence of intrauterine fetal death (IUFD) and stillbirth.
  • In general maternity care, the Royal College of Obstetricians and Gynaecologists (RCOG) Green-top guideline on vaginal birth after caesarean (VBAC) recommends that women should be informed that there is a higher risk of uterine rupture with induction of labour with prostaglandins. The more frequent serious risks of induction of labour with VBAC relate to the fetus, however. In the National Institute of Child Health (NICH) study of 17,898 women with a live fetus undergoing VBAC, the maternal morbidity associated with VBAC (including induced and augmented labours) was a higher risk of endometritis (odds ratio [OR] 1.62, confidence interval [CI] 1.40–1.87), blood transfusion (OR 1.71, CI 1.41–2.08) and scar dehiscence/rupture (0.7%). There was no evidence of an increased rate of hysterectomy or maternal death. Of a subset of 4708 women who had had labour induced, 48 had scar problems (1%).
  • Prostaglandins, given to induce labour, are associated with pyrexia.
  • Disseminated intravascular coagulation (DIC) increases the chance of subdural and epidural haematomata with regional anaesthesia.

Contraindications

Contraindications
  • Dopamine agonists are contraindicated in women with hypertension or pre-eclampsia. They can increase blood pressure and have been associated with intracerebral haemorrhage.
  • Fetal and placental tissues for karyotype (and possible single-gene testing) and postmortem examination are absolutely contraindicated if parents do not wish (written consent essential).
  • The Society of Obstetricians and Gynaecologists of Canada recommended that misoprostol is contraindicated in women with previous caesarean delivery because of a high rate of uterine rupture. A more recent narrative review of induction of labour for late intrauterine fetal death concluded that misoprostol can be used safely at lower doses for women with a previous caesarean (25–50 micrograms). This recommendation has been endorsed by the National Institute for Health and Clinical Excellence (NICE).

Qualifying Statements

Qualifying Statements
  • These recommendations are not intended to dictate an exclusive course of management or treatment. They must be evaluated with reference to individual patient needs, resources and limitations unique to the institution and variations in local populations. It is hoped that this process of local ownership will help to incorporate these guidelines into routine practice. Attention is drawn to areas of clinical uncertainty where further research might be indicated.
  • The Royal College of Obstetricians and Gynaecologists (RCOG) produces guidelines as an educational aid to good clinical practice. They present recognised methods and techniques of clinical practice, based on published evidence, for consideration by obstetricians and gynaecologists and other relevant health professionals. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor or other attendant in the light of clinical data presented by the patient and the diagnostic and treatment options available within the appropriate health services.
  • This means that RCOG Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to be prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or guidelines should be fully documented in the patient's case notes at the time the relevant decision is taken.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Audit Criteria/Indicators
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Royal College of Obstetricians and Gynaecologists (RCOG). Late intrauterine fetal death and stillbirth. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2010 Oct. 33 p. (Green-top guideline; no. 55).  [176 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Oct
Guideline Developer(s)
Royal College of Obstetricians and Gynaecologists - Medical Specialty Society
Source(s) of Funding

Royal College of Obstetricians and Gynaecologists

Guideline Committee

Guidelines Committee

Composition of Group That Authored the Guideline

Authors: Dr D Siassakos, MRCOG, Bristol; Dr R Fox, MRCOG, Taunton; Dr T Draycott, FRCOG, Bristol; and Mrs C Winter, RM, Bristol

Peer reviewers: RCOG Consumers' Forum; British Association of Perinatal Medicine; British Maternal and Fetal Medicine Society; Mr D I Fraser, MRCOG, Norwich; Mr R B Beattie FRCOG, Cardiff; Dr A C G Breeze, MRCOG, Nottingham; Professor E S Draper, Professor of Perinatal and Paediatric Epidemiology, University of Leicester; Dr P Cox, Consultant Perinatal Pathologist, Birmingham Women's Hospital; The Child Bereavement Charity; Centre for Maternal and Child Enquiries; Mrs J Frohlich, Deputy Head of Midwifery, Ashford and St Peter's NHS Trust, Chertsey; Professor G C S Smith, MRCOG, Cambridge; Professor J Gardosi, Director, Perinatal Institute; Dr A E P Heazell, MRCOG, Manchester; Dr A G Howatson, Consultant Paediatric and Perinatal Pathologist, Royal Hospital for Sick Children, Glasgow, Scotland; Dr I Jeffrey, Perinatal Pathology Service, St George's Hospital, London; Sands; Dr E J Treloar, MRCOG, Bristol; Royal College of Paediatrics and Child Health; Obstetric Anaesthetists' Association

Committee lead peer reviewers: Mrs C E Overton, FRCOG, Dr J Thomas, MRCOG, Dr S K Surendran, FRCOG and Dr P Owen, MRCOG

Financial Disclosures/Conflicts of Interest

Guideline authors are required to complete a "declaration of interests" form.

Guideline Status

This is the current release of the guideline.

Guideline Availability
Availability of Companion Documents

The following are available:

  • Development of RCOG Green-top guidelines: policies and processes. Clinical Governance Advice No 1a. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2006 Nov. 6 p. Electronic copies: Available from the Royal College of Obstetricians and Gynaecologists (RCOG) Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: producing a scope. Clinical Governance Advice No 1b. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2006 Nov. 4 p. Electronic copies: Available from the RCOG Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: producing a clinical practice guideline. Clinical Governance Advice No 1c. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2006 Nov. 13 p. Electronic copies: Available from the RCOG Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: consensus methods for adaptation of Green-top guidelines. Clinical Governance Advice No 1d. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2010 Feb. 9 p. Electronic copies: Available from the RCOG Web site External Web Site Policy.

In addition, auditable standards can be found in section 11.5 of the original guideline document External Web Site Policy.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on June 10, 2011. The information was verified by the guideline developer on July 22, 2011.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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