Progesterone in Patients With Placenta Previa

NCT ID: NCT03633175

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2019-08-31

Brief 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.

Detailed 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.

Conditions

Placenta Previa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaginal progesterone group

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).

Group Type: ACTIVE_COMPARATOR

Vaginal progesterone

Intervention Type: DRUG

400 mg vaginal progesterone \[Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt\] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer).

Control group

Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vaginal progesterone

400 mg vaginal progesterone \[Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt\] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer).

Intervention Type: DRUG

Other Intervention Names

Prontogest® suppositories

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

mohammed mahmoud samy

Lecturer in Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Samy, MD

Role: PRINCIPAL_INVESTIGATOR

M Samy

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Samy, MD

Role: CONTACT

mohammedsamy8132@gmail.com

01001947488

Facility Contacts

Mohamed Samy, MD

Role: primary

mohammedsamy8132@gmail.com

01001947488

Other Identifiers

progesterone

Identifier Type: -

Identifier Source: org_study_id