Progesterone vaginal gel for the reduction of recurrent preterm birth

Primary results from a randomized, double-blind, placebo-controlled trial

J. M. O'Brien, Charles Adair, D. F. Lewis, D. R. Hall, E. A. DeFranco, S. Fusey, P. Soma-Pillay, K. Porter, H. How, R. Schackis, D. Eller, Y. Trivedi, G. Vanburen, M. Khandelwal, K. Trofatter, D. Vidyadhari, J. Vijayaraghavan, J. Weeks, B. Dattel, E. Newton & 5 others C. Chazotte, G. Valenzuela, P. Calda, M. Bsharat, G. W. Creasy

Research output: Contribution to journalArticle

191 Citations (Scopus)

Abstract

Objective: Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth. Methods: This randomized, double-blind, placebo-controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once-daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at ≤ 32 weeks of gestation. The trial was analyzed using an intent-to-treat strategy. Results: Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at ≤ 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups. Conclusion: Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (≤ 32 weeks) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation.

Original languageEnglish (US)
Pages (from-to)687-696
Number of pages10
JournalUltrasound in Obstetrics and Gynecology
Volume30
Issue number5
DOIs
StatePublished - Oct 1 2007

Fingerprint

Foams and Jellies Vaginal Creams
Premature Birth
Progesterone
Placebos
Pregnancy
Intravaginal Administration
Tocolysis
Morbidity
Therapeutics
Premature Obstetric Labor
Perinatal Mortality
Gestational Age
Pregnant Women
Rupture
History
Mothers
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Radiological and Ultrasound Technology
  • Reproductive Medicine
  • Radiology Nuclear Medicine and imaging
  • Obstetrics and Gynecology

Cite this

Progesterone vaginal gel for the reduction of recurrent preterm birth : Primary results from a randomized, double-blind, placebo-controlled trial. / O'Brien, J. M.; Adair, Charles; Lewis, D. F.; Hall, D. R.; DeFranco, E. A.; Fusey, S.; Soma-Pillay, P.; Porter, K.; How, H.; Schackis, R.; Eller, D.; Trivedi, Y.; Vanburen, G.; Khandelwal, M.; Trofatter, K.; Vidyadhari, D.; Vijayaraghavan, J.; Weeks, J.; Dattel, B.; Newton, E.; Chazotte, C.; Valenzuela, G.; Calda, P.; Bsharat, M.; Creasy, G. W.

In: Ultrasound in Obstetrics and Gynecology, Vol. 30, No. 5, 01.10.2007, p. 687-696.

Research output: Contribution to journalArticle

O'Brien, JM, Adair, C, Lewis, DF, Hall, DR, DeFranco, EA, Fusey, S, Soma-Pillay, P, Porter, K, How, H, Schackis, R, Eller, D, Trivedi, Y, Vanburen, G, Khandelwal, M, Trofatter, K, Vidyadhari, D, Vijayaraghavan, J, Weeks, J, Dattel, B, Newton, E, Chazotte, C, Valenzuela, G, Calda, P, Bsharat, M & Creasy, GW 2007, 'Progesterone vaginal gel for the reduction of recurrent preterm birth: Primary results from a randomized, double-blind, placebo-controlled trial', Ultrasound in Obstetrics and Gynecology, vol. 30, no. 5, pp. 687-696. https://doi.org/10.1002/uog.5158
O'Brien, J. M. ; Adair, Charles ; Lewis, D. F. ; Hall, D. R. ; DeFranco, E. A. ; Fusey, S. ; Soma-Pillay, P. ; Porter, K. ; How, H. ; Schackis, R. ; Eller, D. ; Trivedi, Y. ; Vanburen, G. ; Khandelwal, M. ; Trofatter, K. ; Vidyadhari, D. ; Vijayaraghavan, J. ; Weeks, J. ; Dattel, B. ; Newton, E. ; Chazotte, C. ; Valenzuela, G. ; Calda, P. ; Bsharat, M. ; Creasy, G. W. / Progesterone vaginal gel for the reduction of recurrent preterm birth : Primary results from a randomized, double-blind, placebo-controlled trial. In: Ultrasound in Obstetrics and Gynecology. 2007 ; Vol. 30, No. 5. pp. 687-696.
@article{8ed322f375454b598f103608e85b06e8,
title = "Progesterone vaginal gel for the reduction of recurrent preterm birth: Primary results from a randomized, double-blind, placebo-controlled trial",
abstract = "Objective: Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth. Methods: This randomized, double-blind, placebo-controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once-daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at ≤ 32 weeks of gestation. The trial was analyzed using an intent-to-treat strategy. Results: Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at ≤ 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups. Conclusion: Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (≤ 32 weeks) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation.",
author = "O'Brien, {J. M.} and Charles Adair and Lewis, {D. F.} and Hall, {D. R.} and DeFranco, {E. A.} and S. Fusey and P. Soma-Pillay and K. Porter and H. How and R. Schackis and D. Eller and Y. Trivedi and G. Vanburen and M. Khandelwal and K. Trofatter and D. Vidyadhari and J. Vijayaraghavan and J. Weeks and B. Dattel and E. Newton and C. Chazotte and G. Valenzuela and P. Calda and M. Bsharat and Creasy, {G. W.}",
year = "2007",
month = "10",
day = "1",
doi = "10.1002/uog.5158",
language = "English (US)",
volume = "30",
pages = "687--696",
journal = "Ultrasound in Obstetrics and Gynecology",
issn = "0960-7692",
publisher = "John Wiley and Sons Ltd",
number = "5",

}

TY - JOUR

T1 - Progesterone vaginal gel for the reduction of recurrent preterm birth

T2 - Primary results from a randomized, double-blind, placebo-controlled trial

AU - O'Brien, J. M.

AU - Adair, Charles

AU - Lewis, D. F.

AU - Hall, D. R.

AU - DeFranco, E. A.

AU - Fusey, S.

AU - Soma-Pillay, P.

AU - Porter, K.

AU - How, H.

AU - Schackis, R.

AU - Eller, D.

AU - Trivedi, Y.

AU - Vanburen, G.

AU - Khandelwal, M.

AU - Trofatter, K.

AU - Vidyadhari, D.

AU - Vijayaraghavan, J.

AU - Weeks, J.

AU - Dattel, B.

AU - Newton, E.

AU - Chazotte, C.

AU - Valenzuela, G.

AU - Calda, P.

AU - Bsharat, M.

AU - Creasy, G. W.

PY - 2007/10/1

Y1 - 2007/10/1

N2 - Objective: Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth. Methods: This randomized, double-blind, placebo-controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once-daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at ≤ 32 weeks of gestation. The trial was analyzed using an intent-to-treat strategy. Results: Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at ≤ 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups. Conclusion: Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (≤ 32 weeks) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation.

AB - Objective: Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth. Methods: This randomized, double-blind, placebo-controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once-daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at ≤ 32 weeks of gestation. The trial was analyzed using an intent-to-treat strategy. Results: Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at ≤ 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups. Conclusion: Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (≤ 32 weeks) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation.

UR - http://www.scopus.com/inward/record.url?scp=35348934298&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=35348934298&partnerID=8YFLogxK

U2 - 10.1002/uog.5158

DO - 10.1002/uog.5158

M3 - Article

VL - 30

SP - 687

EP - 696

JO - Ultrasound in Obstetrics and Gynecology

JF - Ultrasound in Obstetrics and Gynecology

SN - 0960-7692

IS - 5

ER -