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Cochrane Database of Systematic Reviews

Progestogen for treating threatened miscarriage

Information

DOI:
https://doi.org/10.1002/14651858.CD005943.pub5Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 06 August 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:

  1. Cochrane Pregnancy and Childbirth Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Hayfaa A Wahabi

    Correspondence to: Chair of Evidence‐Based Healthcare and Knowledge Translation, King Saud University, Riyadh, Saudi Arabia

    [email protected]

  • Amel A Fayed

    College of Medicine, Clinical Department, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia

  • Samia A Esmaeil

    Department of Family and Community Medicine, King Saud University, Riyadh, Saudi Arabia

  • Khawater Hassan Bahkali

    Department of Family and Community Medicine, King Saud University, Riyadh, Saudi Arabia

Contributions of authors

For the 2017 update, Dr Hayfaa Wahabi participated in the selection of eligible trials, assessment of the trials for inclusion, data extraction and analysis and grading of evidence. She participated in writing both the initial and final version of the review.

Dr Amel Fayed participated in the selection of eligible trials, assessment of the trials for inclusion, data extraction and analysis.

Dr. Khawater Bahkali participated in the selection of eligible trials, assessment of the trials for inclusion, data extraction and analysis and grading of evidence. She participated in writing the draft of the review.

Dr Samia Ahmed participated in the selection of eligible trials, assessment of the trials for inclusion, and data extraction. She participated in writing the draft of the review.

Sources of support

Internal sources

  • Cochrane Review Initiative Project, Saudi Arabia.

External sources

  • No sources of support supplied

Declarations of interest

Hayfaa A Wahabi: none known
Amel A Fayed: none known
Samia A Esmaeil: none known
Khawater Hassan Bahkali: none known

Acknowledgements

The authors extend their gratitude to King Saud University, Deanship of Scientific Research, Research Chairs, for funding this update of the review.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2018 Aug 06

Progestogen for treating threatened miscarriage

Review

Hayfaa A Wahabi, Amel A Fayed, Samia A Esmaeil, Khawater Hassan Bahkali

https://doi.org/10.1002/14651858.CD005943.pub5

2011 Dec 07

Progestogen for treating threatened miscarriage

Review

Hayfaa A Wahabi, Amel A Fayed, Samia A Esmaeil, Rasmieh A Al Zeidan

https://doi.org/10.1002/14651858.CD005943.pub4

2011 Mar 16

Progestogen for treating threatened miscarriage

Review

Hayfaa A Wahabi, Nuha F Abed Althagafi, Mamoun Elawad, Rasmieh A Al Zeidan

https://doi.org/10.1002/14651858.CD005943.pub3

2007 Jul 18

Progestogen for treating threatened miscarriage

Review

Hayfaa A Wahabi, Nuha F Abed Althagafi, Mamoun Elawad, Rasmieh A Al Zeidan

https://doi.org/10.1002/14651858.CD005943.pub2

2006 Apr 19

Progestogen for treating threatened miscarriage

Protocol

Hayfaa A Wahabi, Nuha F Abed, Mamoun Elawad

https://doi.org/10.1002/14651858.CD005943

Differences between protocol and review

  1. The primary outcome 'Miscarriage', was previously listed as 'Early miscarriage up to 12 weeks' and 'Miscarriage later than 12 weeks and less than 23 weeks'. We grouped both outcomes together because the protocol stated that a subgroup analysis for early and late miscarriage would be carried out when data were available

  2. The following outcomes are included in this update.

    1. For the mother:

      1. pregnancy‐induced hypertension

      2. antepartum haemorrhage

    2. For the child:

      1. intrauterine growth restriction

      2. low birthweight

      3. birthweight

      4. respiratory distress syndrome

  3. The methods have been updated to reflect the latest Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).

For this update, we assessed trial quality for seven selected outcomes using the GRADE approach (see summary of findings Table for the main comparison).

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Pregnancy;

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Trial flow diagram
Figures and Tables -
Figure 1

Trial flow diagram

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Risk of bias summary: review authors' judgements about each risk of bias item for each included trial
Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials
Figures and Tables -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 1 Miscarriage.
Figures and Tables -
Analysis 1.1

Comparison 1 Progestogens versus placebo or no treatment, Outcome 1 Miscarriage.

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 2 Preterm birth.
Figures and Tables -
Analysis 1.2

Comparison 1 Progestogens versus placebo or no treatment, Outcome 2 Preterm birth.

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 3 Pregnancy‐induced hypertension.
Figures and Tables -
Analysis 1.3

Comparison 1 Progestogens versus placebo or no treatment, Outcome 3 Pregnancy‐induced hypertension.

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 4 Antepartum haemorrhage.
Figures and Tables -
Analysis 1.4

Comparison 1 Progestogens versus placebo or no treatment, Outcome 4 Antepartum haemorrhage.

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 5 Stillbirth.
Figures and Tables -
Analysis 1.5

Comparison 1 Progestogens versus placebo or no treatment, Outcome 5 Stillbirth.

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Comparison 1 Progestogens versus placebo or no treatment, Outcome 6 Congential abnormalities.
Figures and Tables -
Analysis 1.6

Comparison 1 Progestogens versus placebo or no treatment, Outcome 6 Congential abnormalities.

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Summary of findings for the main comparison. Progesterone compared to placebo or no treatment for treating threatened miscarriage

Progesterone compared to placebo or no treatment for treating threatened miscarriage

Patient or population: women with threatened miscarriage
Setting: two in high‐income countries (Germany and Italy), four in upper‐middle income countries (two in Iran, one in Malaysia and one in Turkey) and one in lower‐income country (Jordan). All in hospitals (university or women's) or medical centres
Intervention: progesterone
Comparison: placebo or no treatment

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(trials)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo or no treatment

Risk with progesterone

Miscarriage

Study population

RR 0.64
(0.47 to 0.87)

696
(7 RCTs)

⊕⊕⊕⊝
Moderate1

242 per 1000

138 per 1000
(102 to 189)

Preterm birth

Study population

RR 0.86
(0.52 to 1.44)

588
(5 RCTs)

⊕⊕⊝⊝
Low1, 2

91 per 1000

84 per 1000
(49 to 142)

Congential abnormalities

Study population

RR 0.70
(0.10 to 4.82)

337
(2 RCTs)

⊕⊝⊝⊝
Very low1, 2, 3

13 per 1000

9 per 1000
(1 to 62)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Random sequence generation and/or allocation concealment had a high or unclear risk of bias in the majority of the trials (methodological quality of trials) (‐1).
2Wide confidence interval crossing the no effect line (imprecision) (‐1).
3A small number of events (‐1).

Figures and Tables -
Summary of findings for the main comparison. Progesterone compared to placebo or no treatment for treating threatened miscarriage
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Comparison 1. Progestogens versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Miscarriage Show forest plot

7

696

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.47, 0.87]

1.1 Oral progestogen versus no treatment

3

408

Risk Ratio (M‐H, Fixed, 95% CI)

0.57 [0.38, 0.85]

1.2 Vaginal progesterone versus placebo

4

288

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.47, 1.21]

2 Preterm birth Show forest plot

5

588

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.52, 1.44]

3 Pregnancy‐induced hypertension Show forest plot

2

337

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.54, 1.88]

4 Antepartum haemorrhage Show forest plot

2

337

Risk Ratio (M‐H, Fixed, 95% CI)

0.76 [0.30, 1.94]

5 Stillbirth Show forest plot

2

262

Risk Ratio (M‐H, Fixed, 95% CI)

1.94 [0.18, 20.49]

6 Congential abnormalities Show forest plot

2

337

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.10, 4.82]
Figures and Tables -
Comparison 1. Progestogens versus placebo or no treatment
Navigate to table in Review