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Vaginal Progesterone Versus Placebo in Multiple Pregnancy

2014-08-27 03:43:51 | BioPortfolio

Summary

The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

Description

Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Preterm Birth

Intervention

Vaginal progesterone gel and placebo gel

Location

Calgary Health Region
Calgary
Alberta
Canada
T2N 2T9

Status

Recruiting

Source

University of Calgary

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:51-0400

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PubMed Articles [3648 Associated PubMed Articles listed on BioPortfolio]

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Safety and efficacy of the cervical pessary combined with vaginal progesterone for the prevention of spontaneous preterm birth.

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Effects of vaginal progesterone for maintenance tocolysis on uterine electrical activity.

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Cervical HSV-2 infection causes cervical remodeling and increases risk for ascending infection and preterm birth.

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Medical and Biotech [MESH] Definitions

Specific proteins found in or on cells of progesterone target tissues that specifically combine with progesterone. The cytosol progesterone-receptor complex then associates with the nucleic acids to initiate protein synthesis. There are two kinds of progesterone receptors, A and B. Both are induced by estrogen and have short half-lives.

Steroidal compounds related to PROGESTERONE, the major mammalian progestational hormone. Progesterone congeners include important progesterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with progestational activities.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Delivery of an infant through the vagina in a female who has had a prior cesarean section.

Allowing a woman to be in LABOR, OBSTETRIC long enough to determine if vaginal birth may be anticipated.

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