-
Ultrasound Obstet Gynecol · Oct 2007
Randomized Controlled Trial Multicenter StudyProgesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial.
- J M O'Brien, C D 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, C Chazotte, G Valenzuela, P Calda, M Bsharat, and G W Creasy.
- Perinatal Diagnostic Center, Central Baptist Hospital, Lexington, Kentucky, USA. jobrien@bhsi.com
- Ultrasound Obstet Gynecol. 2007 Oct 1; 30 (5): 687-96.
ObjectivePreterm 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.MethodsThis 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.ResultsBaseline 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.ConclusionProphylactic 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.Copyright (c) 2007 ISUOG
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*
,_underline_
or**bold**
. - Superscript can be denoted by
<sup>text</sup>
and subscript<sub>text</sub>
. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3.
, hyphens-
or asterisks*
. - Links can be included with:
[my link to pubmed](http://pubmed.com)
- Images can be included with:
![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
- For footnotes use
[^1](This is a footnote.)
inline. - Or use an inline reference
[^1]
to refer to a longer footnote elseweher in the document[^1]: This is a long footnote.
.