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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02697331
Other study ID # AIN-2222-RCT
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 5, 2016
Est. completion date December 28, 2019

Study information

Verified date May 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 28, 2019
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
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:
Placebo
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

Locations

Country Name City State
Egypt Ain Shams University, Maternity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary delivery at <37weeks of gestation Preterm birth 37 weeks gestation determined by 12 weeks dating scan
Secondary adverse neonatal outcome admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis From date of delivery to date of hospital discharge up to 28 days
Secondary preterm Delivery for different gestational age preterm delivery less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
Secondary Maternal adverse effects Drug adverse effects From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner
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