Vaginal Progesterone in Twin With Short Cervix

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Preterm Birth; Twin Dichorionic Diamniotic Placenta

Treatments: Drug: Progesterone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02697331

AIN-2222-RCT

Details and patient eligibility

About

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).

Full 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).

Enrollment: 144 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

progesterone

Active Comparator group

Description:

74 patients will receive progesterone pessary 200mg twice daily

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

74 patients will receive placebo

Treatment:

Other: Placebo