Vaginal Progesterone in Twin With Short Cervix

NCT02697331 | Completed Phase 3

• 1 other identifier: AIN-2222-RCT
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix . Study Design: The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).

Conditions

Preterm Birth; Twin Dichorionic Diamniotic Placenta

Keywords

Short cervix, twins, progesterone

Outcome Measures

Primary Outcomes (1)

• delivery at <37weeks of gestation

  Preterm birth

  37 weeks gestation determined by 12 weeks dating scan

Secondary Outcomes (3)

• adverse neonatal outcome

  From date of delivery to date of hospital discharge up to 28 days

• preterm Delivery for different gestational age

  less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks

• Maternal adverse effects

  From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner

Study Arms (2)

progesterone

ACTIVE COMPARATOR

74 patients will receive progesterone pessary 200mg twice daily

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

74 patients will receive placebo

Other: Placebo

Interventions

Progesterone DRUG

women will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day . women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks

Also known as: uterocare

progesterone

Placebo OTHER

women will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ( Dichorionic Diamniotic twins ) and both twins are living .
• (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks .

You may not qualify if:

• Cervical cerclage in place or planned . 2- on tocolytic drugs . 3- medically indicated preterm delivery \< 35w of gestation . 4- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
• known contraindication to progesterone
• Liver dysfunction or disease
• Known or suspected malignancy of breast or genital organs
• Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder 6- known major structural or chromosomal fetal abnormality . 7- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Mohamed Abdelhafeez

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 3, 2016
• Study Start: April 5, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 28, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

EG (1)