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Vaginal Progesterone in Twin With Short Cervix

Primary Purpose

Preterm Birth, Twin Dichorionic Diamniotic Placenta

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Short cervix, twins, progesterone

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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)

Sites / Locations

  • Ain Shams University, Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

progesterone

Placebo

Arm Description

74 patients will receive progesterone pessary 200mg twice daily

74 patients will receive placebo

Outcomes

Primary Outcome Measures

delivery at <37weeks of gestation
Preterm birth

Secondary Outcome Measures

adverse neonatal outcome
admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis
preterm Delivery for different gestational age
preterm delivery
Maternal adverse effects
Drug adverse effects

Full Information

First Posted
February 27, 2016
Last Updated
May 19, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02697331
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

5. Study Description

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: ( 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Twin Dichorionic Diamniotic Placenta
Keywords
Short cervix, twins, progesterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
progesterone
Arm Type
Active Comparator
Arm Description
74 patients will receive progesterone pessary 200mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
74 patients will receive placebo
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
uterocare
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
delivery at <37weeks of gestation
Description
Preterm birth
Time Frame
37 weeks gestation determined by 12 weeks dating scan
Secondary Outcome Measure Information:
Title
adverse neonatal outcome
Description
admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis
Time Frame
From date of delivery to date of hospital discharge up to 28 days
Title
preterm Delivery for different gestational age
Description
preterm delivery
Time Frame
less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
Title
Maternal adverse effects
Description
Drug adverse effects
Time Frame
From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: ( 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelhafeez
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University, Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Vaginal Progesterone in Twin With Short Cervix

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