Progesterone in Patients With Placenta Previa

Last updated: August 15, 2018
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

2

Condition

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT03633175
progesterone
  • Ages 18-40
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Gestational age 26-28 weeks of gestation.

  2. Definite and reliable diagnosis of placenta previa (defined as presence of a placentawithin 2 cm of the internal os), using a transvaginal ultrasound scan.

Exclusion

Exclusion Criteria:

  1. Multiple pregnancy.

  2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor orpreterm prelabor rupture of the membranes (PPROM).

  3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgentintervention and delivery.

  4. Women who have been maintained on progestin therapy since early pregnancy for whateverreason.

Study Design

Total Participants: 74
Study Start date:
July 05, 2018
Estimated Completion Date:
August 31, 2019

Study 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.

Connect with a study center

  • Ain SHams Maternity Hospital

    Cairo, Abbaseya 002
    Egypt

    Active - Recruiting

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