Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

[Intervention Review]
Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

Jodie M Dodd1, Vicki Flenady2, Robert Cincotta3, Caroline A Crowther4

1School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia. 2Mater Mother's Research Centre, Mater Health Services, Wooloongabba, Australia. 3Department of Maternal Fetal Medicine, Mater Mothers' Hospital, South Brisbane, Australia. 4ARCH: Australian Research Centre for Health of Women and Babies, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia

Contact address: Jodie M Dodd, School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, 72 King William Road, Adelaide, South Australia, 5006, Australia. jodie.dodd@adelaide.edu.au. (Editorial group: Cochrane Pregnancy and Childbirth Group.)

Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: New search for studies completed, conclusions not changed)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD004947.pub2
This version first published online: 25 January 2006 in Issue 1, 2006. Last assessed as up-to-date: 30 December 2008. (Help document - Dates and Statuses explained).

This record should be cited as: Dodd JM, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004947. DOI: 10.1002/14651858.CD004947.pub2.
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Abstract


Background
Preterm birth is a major complication of pregnancy associated with perinatal mortality and morbidity. Progesterone for the prevention of preterm labour has been advocated.


Objectives
To assess the benefits and harms of progesterone for the prevention of preterm birth for women considered to be at increased risk of preterm birth.


Search strategy
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2008) and the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 1).


Selection criteria
Randomised controlled trials, in which progesterone was given for preventing preterm birth.


Data collection and analysis
Two authors independently evaluated trials for methodological quality and extracted data.


Main results
Eleven randomised controlled trials (2714 women and 3452 infants) were included.

Progesterone versus placebo for women with a past history of spontaneous preterm birth
Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks' gestation (one study; 142 women; risk ratio (RR) 0.15; 95% confidence interval (CI) 0.04 to 0.64); preterm birth less than 37 weeks' gestation (four studies; 1255 women; RR 0.80; 95% CI 0.70 to 0.92); infant birthweight less than 2500 grams (two studies; 501 infants; RR 0.64; 95% CI 0.49 to 0.83).

Progesterone versus placebo for women with a short cervix identified on ultrasound
Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks (one study; 250 women; RR 0.58; 95% CI 0.38 to 0.87); and neonatal sepsis (one study; 274 infants; RR 0.28; 95% CI 0.08 to 0.97).

Progesterone versus placebo for women with a multiple pregnancy
Progesterone was associated with a statistically significant reduction in the risk of antenatal tocolysis (one study; 654 women; RR 0.75; 95% CI 0.57 to 0.97).

Progesterone versus placebo for women following presentation with threatened preterm labour
Progesterone, was associated with a statistically significant reduction in the risk of preterm birth less than 37 weeks (one study; 60 women; RR 0.29; 95% CI 0.12 to 0.69), infant birthweight less than 2500 grams (one study; 70 infants; RR 0.52; 95% CI 0.28 to 0.98); and respiratory distress syndrome (one study; 70 infants; RR 0.30; 95% CI 0.11 to 0.83).

Progesterone versus placebo for women with 'other' risk factors for preterm birth
Progesterone was associated with no statistically significant differences for the reported outcomes.


Authors' conclusions
Further trials are required to assess the benefits and harms of progesterone therapy when given to women considered to be at increased risk of early birth.


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Plain language summary

Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth
Babies who are born before 37 weeks, and particularly those born before 34 weeks, are at greater risk of suffering problems at birth. Progesterone is a hormone that inhibits the uterus from contracting and is involved in maintaining pregnancy. The review of eleven randomised controlled trials, involving a total of 2714 women and 3452 infants, found that where progesterone was given (by injection into the muscle in some studies and as a pessary into the vagina in others), there were some beneficial effects, including prolonging the pregnancy, but there is insufficient information about other possible benefits or harms. Further research is being undertaken.






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