Vaginal Progesterone in Twin With Short Cervix
Condition: Preterm Birth; Twin Dichorionic Diamniotic Placenta
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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; 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
Other intervention name(s): uterocare
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Short cervix, twins, progesterone