Vaginal Progesterone in Twin With Short Cervix

NCT ID: NCT02697331

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-05
• Study Completion Date: 2019-12-28

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).

Detailed Description

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).

Inclusion Criteria :

( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:

1. ( Dichorionic Diamniotic twins ) and both twins are living .

2. (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks

Exclusion Criteria :

1. 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) .

5. known contraindication to progesterone

1. Liver dysfunction or disease

2. Known or suspected malignancy of breast or genital organs

3. 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).

Conditions

Preterm Birth; Twin Dichorionic Diamniotic Placenta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

progesterone

74 patients will receive progesterone pessary 200mg twice daily

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: 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

Placebo

74 patients will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

Progesterone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

uterocare

Eligibility Criteria

Inclusion Criteria

1. ( Dichorionic Diamniotic twins ) and both twins are living .

2. (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks .

Exclusion Criteria

1 - 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) .

5- known contraindication to progesterone

1. Liver dysfunction or disease

2. Known or suspected malignancy of breast or genital organs

3. 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Reda

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Abdelhafeez

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University, Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AIN-2222-RCT

Identifier Type: -

Identifier Source: org_study_id