(983) Vaginal progesterone gel vs. capsule for preterm birth prevention: an indirect comparison meta-analysis

Friday, February 10, 2023

3:30 PM – 5:00 PM

Objective: To evaluate the effectiveness of vaginal progesterone in preventing preterm birth in women with a singleton gestation and short cervical length and to determine which of the two formulations, micronized progesterone vaginal capsule versus vaginal gel is more effective for preventing preterm birth.

Study Design: A systematic search was performed in the following databases: EMBASE, PubMed (MEDLINE), The Cochrane Library, and the Clinical Trials Registry. Randomized controlled trials (RCTs), prospective and retrospective observational studies were included. We searched for progesterone administration in asymptomatic women with a singleton gestation and a shortened cervix ( < 25 mm) in the mid-trimester to prevent preterm birth. The primary outcome was preterm birth <33 weeks of gestation. Pooled relative risks (RR) and 95%CI were calculated for dichotomous outcomes. Heterogeneity of treatment effect was assessed with the I2 statistic. We pooled results of the primary outcome for individual studies using a random-effect model. Then we perform a network meta-analysis to pool indirect comparison between the two formulations (gel vs. capsule). This analysis was performed using the package network meta-analysis within the R environment.

Results: Five studies met the inclusion criteria (4 RCTs, one cohort study); 1,048 women were included. The meta-analysis demonstrated that vaginal micronized progesterone significantly reduces preterm birth risk, Risk Ratio=0.63; 95% CI, 0.48-0.82; P=0.0006; with no heterogeneity between the studies: I2=0%. In the network meta-analysis, no significant difference was demonstrated (OR=0.85; 95% CI, 0.43-1.69) between the effect of the two formulations of vaginal micronized progesterone (vaginal gel versus vaginal capsules) on the risk of PTB.

Conclusion: Vaginal progesterone is associated with a decreased risk of premature birth in women with a shortened cervix in the second trimester of pregnancy. No differences were found between vaginal and oral micronized progesterone treatment.

Primary & Presenting Author(s)

Doron Kabiri, MD (he/him/his)
Hadassah Hebrew University Medical Center
Jerusalem, Israel

Coauthor(s)

YH
Yael Hamou, MPH
Hadassah Hebrew University Medical Center, Yerushalayim, Israel
GG
Gali Gordon, MD
Hadassah Hebrew University Medical Center
Jerusalem, Yerushalayim, Israel
RA
Roei Alter, MD
Hadassah Hebrew University Medical Center
Jerusalem, Yerushalayim, Israel
EK
Einav Kremer, MD, MPH
Hadassah Hebrew University Medical Center
Jerusalem, Yerushalayim, Israel
IM
Ilan Matok, PhD
The Hebrew University of Jerusalem
Jerusalem, Israel, Israel