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«CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE Institute ...»

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CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE

CLINICAL PRACTICE GUIDELINE

MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE

Institute of Obstetricians and Gynaecologists,

Royal College of Physicians of Ireland and

Directorate of Strategy and Clinical Programmes,

Health Service Executive

Version 1.0 Date of publication: April 2012 Guideline No.

10 Revision date: April 2014

CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE

Table of Contents Key recommendations

1. Purpose and Scope

2. Background and Introduction

3. Methodology

4. Service Provision

5. Clinical Guideline

5.1. Terminology

5.2. Clinical Examination

5.3. Diagnosis

5.4. Conservative Management of a miscarriage

5.5. Medical management of a miscarriage

5.6. Surgical management of a miscarriage

5.7. Histological examination of tissue

5.8. Rheus anti-D prophylaxis

5.9. Psychological aspects of miscarriage

6. References

7. Implementation Strategy

8. Key Performance Indicators

9. Qualifying Statement

Appendices

Appendix 1

Appendix 2

Appendix 3

Appendix 4

Appendix 5

–  –  –

Key Recommendations

1. It is important that all relevant staff in the maternity services are familiar with the chronological ultrasound features of early pregnancy to accurately diagnose an early pregnancy loss.

2. This guideline should be read in conjunction with Clinical Practice Guideline:

Ultrasound Diagnosis of Early Pregnancy Miscarriage (January 2011).

3. Women are sensitive about references to pregnancy loss. As their loss is not out of choice, use of language like “abortion” can be sometimes offensive at a vulnerable time. Hence, discussion or documentation of management of early pregnancy loss should be worded appropriately.

4. At all times women should be supported in making informed choices about their care and management. Adequate explanations supplemented with written information should be given.

5. Surgical management of miscarriage should be offered to women who make a specific request, women who change their mind during the course of conservative or medical management, women who have heavy bleeding and/or severe pain, when gestational trophoblastic disease is suspected or if infected intrauterine tissue is present.

6. Conservative management of miscarriage is an effective and acceptable method to offer women. Women should be counselled that complete resolution may take several weeks and that overall efficacy rates may be lower than medical or surgical interventions.

7. Outpatient medical management should be reserved to women with a mean gestational sac diameter 50mm as increased vaginal bleeding may be encountered. Misoprostol is given sublingually in two 600µg doses three hours apart.

8. All professionals should be aware of the psychological sequelae associated with pregnancy loss and should provide support, follow-up and access to formal counselling when necessary. Furthermore, a system must be in place for informing all relevant primary care professionals.

3

CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE

1. Purpose and Scope The purpose of this guideline is to improve the management of women with early pregnancy loss, defined as a loss within the first 12 completed weeks of pregnancy.

It mainly reviews management of spontaneous miscarriage but is also relevant to women affected by ectopic pregnancy and gestational trophoblastic disease.

However, specific recommendations for both these conditions are not covered in this guideline.

The guideline is intended to be primarily used by health personnel working in the area of early pregnancy which includes obstetricians, midwife sonographers, radiographers, radiologists and general practitioners. All of the groups should be familiar with the various diagnostic tools necessary to help delineate a viable from a non-viable pregnancy. It should be read in conjunction with the Clinical Practice Guideline: Ultrasound Diagnosis of Early Pregnancy Miscarriage. This guideline aids clinical judgement and does not replace it. In individual cases a healthcare professional may, after careful consideration, decide not to follow the guideline if it is deemed to be in the best interest of the woman.

2. Background and Introduction Spontaneous miscarriage is the commonest complication of pregnancy. It occurs in up to 20% of clinical pregnancies equating to approximately 14,000 miscarriages per annum in Ireland [Poulose et al, 2006]. Historically, the majority of women who miscarried underwent „routine‟ surgical uterine evacuation; that is, evacuation of retained products of conception (ERPC). In the last 10 years, standard management has changed with the development of more refined diagnostic techniques and therapeutic interventions allowing more treatment to be carried out on an outpatient basis.





3. Methodology This guideline was adapted from the Green-top Guideline No.25, Management of Early Pregnancy loss, October 2006, produced by the Royal College of Obstetrician and Gynaecologists (RCOG) of the United Kingdom [Green Top Guideline 25 (RCOG), 2006]. Furthermore, Medline, EMBASE and Cochrane Database of Systematic Reviews were searched using the terms „miscarriage‟, „spontaneous abortion‟, „uterine evacuation‟ and „prostaglandin (misoprostol)‟. Searches were limited to humans and restricted to the titles of English language articles published between August 1991 and August 2011. Relevant meta-analyses, systematic reviews, intervention and observational studies were reviewed.

Abbreviations ERPC: Evacuation of Retained Products of Conception EPAU: Early pregnancy assessment unit HCG: Human Chorionic Gonadotrophin Ig: Immunoglobulin MGSD: Mean gestational sac diameter

–  –  –

LMP: Last menstrual period PUL: Pregnancy of unknown location TAS: Transabdominal ultrasound scan TVS: Transvaginal ultrasound scan WMD: Weighted mean difference The principal guideline developers were Dr Nadine Farah, Dr Andrea Nugent and Dr Mary Anglim, Coombe Women and Infants University Hospital. The guideline was peer-reviewed by Dr Keelin O‟Donoghue (Cork), Dr Michael Gannon (Mullingar), Professor Michael Turner (HSE), Dr Donal Brennan (JOGS), Ms Jane Leavy (Midwifery), Ms Mary Moran (Midwifery), Dr Emma Kilgariff (GP), Ms Mary Brosnan (Midwifery).

4. Service Provision  All maternity units should provide a dedicated EPAU for the assessment of women with an early pregnancy loss.

The EPAU should open for at least two hours every day Monday to Friday for both planned and emergency appointments in the morning. In larger hospitals, longer opening hours may be necessary.

Outside normal working hours, every unit should have at least one Obstetrician and Gynaecologist available to assess women presenting with early pregnancy emergencies.

 The EPAU service should be comprehensive and ideally sited in a dedicated area with appropriate staffing. There should be direct access for GPs and selected patient groups.

Each EPAU should have at least one properly furnished single room that ensures the couple‟s privacy is respected. The clinical session should be staffed by a midwife sonographer/ radiographer who have been trained in early pregnancy ultrasound and a receptionist/ secretary dedicated to the session. A senior obstetrician should be also available for clinical decisions during each session.

 All staff members working in the EPAU should be aware of the importance of good communication in early pregnancy care, and written information should be available in every EPAU.

5. Clinical guideline

5.1. Terminology Women feel sensitive about the way we refer to pregnancy loss. As their loss is not out of choice, use of language like “abortion” can be sometimes offensive to women at this vulnerable time. Hence documentation and discussion of early pregnancy loss should be worded appropriately.

5

CLINICAL PRACTICE GUIDELINE MANAGEMENT OF EARLY PREGNANCY MISCARRIAGE

All women attending the EPAU should be given a diagnosis and grouped under respective diagnostic groups, such as: viable pregnancy, pregnancy of uncertain viability, early pregnancy loss, incomplete miscarriage, complete miscarriage, pregnancy of unknown location (PUL), ectopic pregnancy and hydatidiform mole.

 Viable intrauterine pregnancy:

Is when there is a normally sited gestational sac with a fetal pole and clearly identified cardiac activity. Demonstration of fetal heart activity is generally associated with a successful pregnancy rate of 85-97%, depending on the period of gestation [Johns et al, 2003]. A follow up appointment may be required in the following situations: there is significant vaginal bleeding, a subchorionic haematoma is noted, fetal bradycardia is noted, for reassurance at patient‟s request because of previous miscarriages or after intrauterine contraceptive device removal.

 Pregnancy of uncertain viability:

Is when there is a normally sited gestational sac and the mean gestational sac diameter (MGSD) ≤ 20 mm and no fetal pole is seen or when there is a normally sited gestational sac with a fetal pole ≤ 7 mm present and no fetal heart pulsation is seen on a TVS [Clinical Practice Guideline, 2011)]. In woman with a pregnancy of uncertain viability a follow up repeat scan needs to be organised at least 7 days from the original scan to assess growth of the gestation sac or embryo and to establish whether fetal heart activity develops.

 Early pregnancy loss (delayed miscarriage):

Is when the:

- MGSD 20 mm with no fetal pole on TVS or a MGSD 25 mm with no fetal pole on transabdominal scan (TAS)

- Fetal pole 7 mm with no fetal heart pulsation on TVS or a Fetal pole 8 mm with no fetal heart pulsation on TAS

- When the MGSD is ≤ 20 mm with no fetal pole or if the fetal pole is ≤ 7 mm and no fetal heart pulsation is seen and a repeat TVS organised at least 7 days from the original scan demonstrates little or no change in the dimensions

- When the MGSD is ≤ 25 mm with no fetal pole or if the fetal pole is ≤ 8 mm and no fetal heart pulsation is seen and a repeat TAS organised at least 7 days from the original scan demonstrates little or no change in the dimensions.

However it is important to keep in mind when making a diagnosis that the inter and intraobserver variability of the MGSD and fetal pole measurements reveals, for MGSD, the limits of agreement to be ±18 % [Pexsters et al, 2011]. So, a MGSD measurement of 20 mm by one examiner may translate to a measurement of anywhere between 17 and 25 mm for a second examiner. Taking inter- and intraobserver variation of measurements into account, an empty MGSD cut-off of 25 mm and a CRL cut-off of 7 mm could be introduced and, based on the available evidence, would be associated with a minimal risk of a false-positive diagnosis of miscarriage [Abdallah et al, 2011]. Emphasis should be placed on the need to repeat scans when measurements are around the decision boundaries.

–  –  –

Incomplete miscarriage:

Is when on ultrasound scan the intrauterine tissue diameter is ≥ 15 mm  Complete miscarriage Is when on ultrasound scan the endometrial thickness is 15mm and there was previous evidence of an intrauterine gestational sac or retained products of conception.

 Pregnancy of unknown location:

Is when there are no signs of either intra- or extrauterine pregnancy or retained products of conception in a woman with a positive pregnancy test. There could be three reasons for a scan result to be classified as a PUL: a very early intrauterine pregnancy or a complete miscarriage or an early ectopic pregnancy. At subsequent follow up visits the diagnosis may become clear.

Even with expert use of TVS using agreed criteria, it may not be possible to confirm if a pregnancy is intrauterine or extrauterine in 8–31% of cases at the first visit [Condus et al, 2003]. In specialised scanning units, the overall incidence of PUL is as low as 8–10%.

5.2. Clinical examination in the EPAU  A brief history should be taken to include:

- Previous obstetric history, LMP and a urine pregnancy test in this pregnancy

- If there is pain and, if so, its description

- If there is bleeding and, if so, the amount and whether products of conception were passed  Clinical examination should be considered if appropriate In the absence of a clinical indication, pregnant women should be discouraged from presenting for an ultrasound scan before 8 weeks gestation. Examples of a clinical indication include pelvic pains, vaginal bleeding or a previous ectopic pregnancy.

Pregnant women with a long menstrual cycle should be discouraged from presenting for a scan until two weeks after their first positive pregnancy test. If a scan is performed too early in pregnancy in an asymptomatic woman simply for reassurance, it may generate more anxiety than it alleviates if the findings are unequivocal.

5.3. Diagnosis and investigation  TVS will be required in the majority of women referred to an EPAU.

The procedure and the reasons for the scan should be explained to the patient. TVS is found to be extremely well tolerated as a technique by most women [Russell et al, 2005]. The woman‟s wishes should be respected if she strongly declines a TVS and if the gender of the professional is particularly important to her.

–  –  –

Appropriate infection control measures must be taken when disinfecting transvaginal ultrasound probes and facilities must ensure that there is strict adherence to current standards of disinfection.

 It is important that all relevant health personnel are familiar with the chronological ultrasound features of early pregnancy [Clinical Practice Guideline, 2011].



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