Progesterone in Patients With Placenta Previa

NCT03633175 | Unknown Phase 2 DMC

• 1 other identifier: progesterone
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• Incidence of preterm delivery due to severe antepartum hemorrhage.

  Number of patients who delivered before 37 weeks gestational age

  from 26 weeks till 37 weeks

Secondary Outcomes (12)

• No. of episodes of antepartum hemorrhage.

  from 26 weeks till 37 weeks

• Hospital admission for significant antepartum hemorrhage.

  from 26 weeks till 37 weeks

• Hospital admission for threatened preterm labor.

  from 26 weeks till 37 weeks

• Need for blood transfusion.

  from 26 weeks till 37 weeks

• Incidence of severe postpartum hemorrhage.

  from 26 weeks till 37 weeks

Study Arms (2)

Vaginal progesterone group

ACTIVE COMPARATOR

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).

Drug: Vaginal progesterone

Control group

NO INTERVENTION

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

Interventions

Vaginal progesterone 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).

Also known as: Prontogest® suppositories

Vaginal progesterone group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Mohamed Samy, MD

  M Samy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Samy, MD

CONTACT

01001947488; mohammedsamy8132@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: August 16, 2018
• Study Start: July 5, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)