Vaginal Progesterone in Twin With Short Cervix

Phase 3

Completed

• Conditions: Twin Dichorionic Diamniotic Placenta; Preterm Birth
• Interventions: Other: Placebo; Drug: Progesterone

• Registration Number: NCT02697331
• Lead Sponsor: Ain Shams University

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).

Study Timeline

• Study First Submitted: 2016-02-27
• Study First Submitted QC: 2016-02-27
• Study First Posted: 2016-03-03
• Study Start: 2016-04-05
• Primary Completion: 2018-09-01
• Study Completion: 2019-12-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	74 patients will receive placebo
progesterone	Progesterone	74 patients will receive progesterone pessary 200mg twice daily

Primary Outcome Measures

Name	Time	Method
delivery at <37weeks of gestation	37 weeks gestation determined by 12 weeks dating scan	Preterm birth

Secondary Outcome Measures

Name	Time	Method
preterm Delivery for different gestational age	less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks	preterm delivery
Maternal adverse effects	From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner	Drug adverse effects
adverse neonatal outcome	From date of delivery to date of hospital discharge up to 28 days	admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis

Trial Locations

Locations (1)

Ain Shams University, Maternity Hospital; 🇪🇬 Cairo, Egypt