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Completed

NCT Number: NCT02697331

Vaginal Progesterone in Twin With Short Cervix

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University, Maternity Hospital

Cairo, Egypt

About this study

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:

  • ( Dichorionic Diamniotic twins ) and both twins are living .
  • (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks

Exclusion criteria

  • Cervical cerclage in place or planned .
  • on tocolytic drugs .
  • medically indicated preterm delivery < 35w of gestation .
  • known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
  • known contraindication to progesterone
  • Liver dysfunction or disease
  • Known or suspected malignancy of breast or genital organs
  • Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder
  • known major structural or chromosomal fetal abnormality .
  • Rupture of fetal membranes (leakage of amniotic fluid one or both sacs).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • ( Dichorionic Diamniotic twins ) and both twins are living .
  • (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

  • Liver dysfunction or disease
  • Known or suspected malignancy of breast or genital organs
  • 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)

Treatment and study plan

Progesterone

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

Other names: uterocare

Placebo

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

Primary outcomes

  1. delivery at <37weeks of gestation

    Time frame: 37 weeks gestation determined by 12 weeks dating scan

    Preterm birth

Secondary outcomes

  1. adverse neonatal outcome

    Time frame: From date of delivery to date of hospital discharge up to 28 days

    admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis

  2. preterm Delivery for different gestational age

    Time frame: less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks

    preterm delivery

  3. Maternal adverse effects

    Time frame: From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner

    Drug adverse effects

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 3, 2016
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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