Vaginal Progesterone in Twin With Short Cervix

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697331
• Other study ID #: AIN-2222-RCT
• Status: Completed
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Twin Dichorionic Diamniotic Placenta

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