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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Twin Pregnancy With Antenatal Problem

Treatments: Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT04748562

MS 483/2019

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

400 mg progesterone group

Active Comparator group

Description:

Taking 400 mg vaginal progesterone

Treatment:

Drug: Progesterone

200 mg progesterone group

Active Comparator group

Description:

Taking 200 mg vaginal progesterone

Treatment:

Drug: Progesterone