Vaginal Progesterone in Twins With Short Cervix

Phase 2

Withdrawn

• Conditions: Premature Birth
• Interventions: Procedure: fetal fibronectin swab.; Drug: Vaginal Progesterone gel.; Drug: Placebo gel

• Registration Number: NCT01812239
• Lead Sponsor: Obstetrix Medical Group

Brief Summary

A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.

Detailed Description

This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-18
• Study Start: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-19
• Primary Completion: 2017-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Gestational age between 20w0d and 24w0d
• Twin pregnancy, diamniotic-dichorionic, both twins living
• Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam

Exclusion Criteria

• Mother less than 18 years of age

• Uterine contractions of 40 seconds duration or more, 10 or more per hour

• Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)

• Ongoing vaginal bleeding

• Any condition likely to cause serious neonatal morbidity independent of gestational age, including:

  1. fetal malformation likely to require surgery
  2. fetal malformation involving vital organs
  3. fetal viral infection
  4. hydrops fetalis
  5. discordance in estimated fetal weight more than 10%
  6. velamentous insertion of umbilical cord of either twin
  7. placenta previa of either placenta

• Any contraindication to continuing the pregnancy

• Cervical cerclage in place or planned

• Any contraindication to vaginal micronized progesterone, including:

  1. Known sensitivity to progesterone or any of the other ingredients
  2. Liver dysfunction or disease
  3. Known or suspected malignancy of breast or genital organs
  4. Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	fetal fibronectin swab.	Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
Vaginal Progesterone	Vaginal Progesterone gel.	Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
Placebo	Placebo gel	Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
Vaginal Progesterone	fetal fibronectin swab.	Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.

Primary Outcome Measures

Name	Time	Method
Birth of baby before 34 weeks of gestation	At the time of delivery	The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation. A birth at 33weeks 6days or earlier is considered to have the primary outcome. A birth at 34weeks 0days or later does not have the primary outcome. Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.

Secondary Outcome Measures

Name	Time	Method
Rate of "spontaneous birth" before 34weeks of gestation	from randomization to birth of the baby - up to 15 weeks	Rate of "spontaneous birth" before 34weeks of gestation. Spontaneous births are those whose underlying cause is judged to be due to preterm labor, prelabor rupture of membranes, or cervical insufficiency. (In contradistinction, "indicated" deliveries are those due to preeclampsia, fetal growth problems, fetal heart rate abnormalities, and other problems.)
Rate of composite neonatal morbidity	measures from randomization to 60 days post delivery of the baby	Composite morbidity is defined as any one or more of: stillbirth, neonatal death, infant death before hospital discharge, respiratory distress syndrome (RDS), intracranial hemorrhage (grade 3 or 4)(IVH), necrotizing enterocolitis (stage 2 or 3)(NEC), documented neonatal sepsis within 72 hr of birth, or periventricular leukomalacia (characteristic lesions in the subcortical white matter seen on cerebral imaging studies within 96 hrs of birth)(PVL).
Gestational age of baby at birth	measure at time of birth	measured of the average Gestational age of babies at birth.

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 San Jose, California, United States