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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04748562

Enrollment

100

Registered

2021-02-10

Start date

2020-01-01

Completion date

2020-12-01

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin Pregnancy With Antenatal Problem

Keywords

Progesterone, Twin pregnancy, Preterm labor

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

Interventions

DRUGProgesterone

Taking prontogest vaginally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Preterm labor	Before 37 weeks gestation	Number of participants which had preterm labor

Secondary

Measure	Time frame	Description
Cervical length changes	Between 14 weeks and 22 weeks gestation	Cervical length changes in centimeters
Neonatal ICU admission	The first 28 days after delivery	Number of neonates required neonatal ICU admission
Neonatal mechanical ventilation	The first 28 days after delivery	Number of neonates required mechanical ventilation
Progesterone side effects	During one year which is the period from the start of the study till its end	The number of patients experiencing progesterone side effects

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026