Progesterone in Patients With Placenta Previa

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

1. Gestational age 26-28 weeks of gestation.
2. 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

1. Multiple pregnancy.
2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
4. 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)

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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.