Clinical trial NCT02697331: Vaginal Progesterone in Twin With Short Cervix
Official title: Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Twin Dichorionic Diamniotic Placenta
Keywords: Short cervix, twins, progesterone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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)

Primary outcomes:
measure: delivery at <37weeks of gestation
timeFrame: 37 weeks gestation determined by 12 weeks dating scan
Secondary outcomes:
measure: adverse neonatal outcome
timeFrame: From date of delivery to date of hospital discharge up to 28 days
measure: preterm Delivery for different gestational age
timeFrame: less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
measure: Maternal adverse effects
timeFrame: From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed Abdelhafeez
role: STUDY_DIRECTOR
References: