A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth

详细信息    查看全文

• 作者：Andrew Elimian^a ; ^{elimiana@wcmc.com" class="auth_mail" title="E-mail the corresponding author} ; Katie Smith^b ; Marvin Williams^b ; Eric Knudtson^b ; Jean R. Goodman^b ; Marilyn B. Escobedo^c
• 关键词：Preterm birth ; Prevention ; Progesterone
• 刊名：International Journal of Gynecology and Obstetrics
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：134
• 期：2
• 页码：169-172
• 全文大小：192 K

文摘

To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth.

Methods

A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16–20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included.

Results

Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular progesterone group and 30 (37.9%) in the vaginal progesterone group (P = 0.50).

Conclusion

Weekly intramuscular administration of hydroxyprogesterone caproate and daily vaginal administration of a progesterone suppository exhibited similar efficacy in reducing the rate of recurrent preterm birth.

ClinicalTrials.gov: NCT00579553.