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

NCT ID: NCT04748562

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Twin Pregnancy With Antenatal Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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400 mg progesterone group

Taking 400 mg vaginal progesterone

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Taking prontogest vaginally

200 mg progesterone group

Taking 200 mg vaginal progesterone

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Taking prontogest vaginally

Interventions

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Progesterone

Taking prontogest vaginally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Primigravidae
2. Twin pregnancies at gestational age 14 week.
3. 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University Maternity hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS 483/2019

Identifier Type: -

Identifier Source: org_study_id

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