Progesterone in Patients With Placenta Previa

A

Ain Shams University

Status and phase

Unknown
Phase 2

Conditions

Placenta Previa

Treatments

Drug: Vaginal progesterone

Study type

Interventional

Funder types

Other

Identifiers

NCT03633175
progesterone

Details and patient eligibility

About

This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.

Full description

Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.

Enrollment

74 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age 26-28 weeks of gestation. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.

Exclusion criteria

Multiple pregnancy. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM). Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. Women who have been maintained on progestin therapy since early pregnancy for whatever reason.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Vaginal progesterone group
Active Comparator group
Description:
Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer).
Treatment:
Drug: Vaginal progesterone
Control group
No Intervention group
Description:
Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.

Trial contacts and locations

1

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Central trial contact

Mohamed Samy, MD

Data sourced from clinicaltrials.gov

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