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Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Primary Purpose

Twin Pregnancy With Antenatal Problem

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Progesterone

About this trial

This is an interventional prevention trial for Twin Pregnancy With Antenatal Problem focused on measuring Progesterone, Twin pregnancy, Preterm labor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Primigravidae
Twin pregnancies at gestational age 14 week.
Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)

Exclusion Criteria:

Polyhydramnios
Anemia
Twins with congenital malformation
Twin to twin transfusion
Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
Previous cervical surgery
High order pregnancy (triples or more)

Sites / Locations

Ain Shams University Maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

400 mg progesterone group

200 mg progesterone group

Arm Description

Taking 400 mg vaginal progesterone

Taking 200 mg vaginal progesterone

Outcomes

Primary Outcome Measures

Preterm labor

Number of participants which had preterm labor

Secondary Outcome Measures

Cervical length changes

Cervical length changes in centimeters

Neonatal ICU admission

Number of neonates required neonatal ICU admission

Neonatal mechanical ventilation

Number of neonates required mechanical ventilation

Progesterone side effects

The number of patients experiencing progesterone side effects

Full Information

NCT ID

NCT04748562

First Posted

January 31, 2021

Last Updated

February 5, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04748562

Brief Title

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Official Title

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

August 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy. There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Twin Pregnancy With Antenatal Problem

Keywords

Progesterone, Twin pregnancy, Preterm labor

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

400 mg progesterone group

Arm Type

Active Comparator

Arm Description

Taking 400 mg vaginal progesterone

Arm Title

200 mg progesterone group

Arm Type

Active Comparator

Arm Description

Taking 200 mg vaginal progesterone

Intervention Type

Drug

Intervention Name(s)

Progesterone

Intervention Description

Taking prontogest vaginally

Primary Outcome Measure Information:

Title

Preterm labor

Description

Number of participants which had preterm labor

Time Frame

Before 37 weeks gestation

Secondary Outcome Measure Information:

Title

Cervical length changes

Description

Cervical length changes in centimeters

Time Frame

Between 14 weeks and 22 weeks gestation

Title

Neonatal ICU admission

Description

Number of neonates required neonatal ICU admission

Time Frame

The first 28 days after delivery

Title

Neonatal mechanical ventilation

Description

Number of neonates required mechanical ventilation

Time Frame

The first 28 days after delivery

Title

Progesterone side effects

Description

The number of patients experiencing progesterone side effects

Time Frame

During one year which is the period from the start of the study till its end

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primigravidae Twin pregnancies at gestational age 14 week. Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.) Exclusion Criteria: Polyhydramnios Anemia Twins with congenital malformation Twin to twin transfusion Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis Previous cervical surgery High order pregnancy (triples or more)

Facility Information:

Facility Name

Ain Shams University Maternity hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

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