Progesterone in Patients With Placenta Previa

Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa

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.

Study Overview

• Status: Unknown
• Conditions: Placenta Previa
• Intervention / Treatment: Drug: Vaginal progesterone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt, 002
      • Recruiting
      • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: 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).; Other Names: Prontogest® suppositories
No Intervention: Control group; Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
No. of episodes of antepartum hemorrhage.	Mean number of episodes of antepartum hemorrhage	from 26 weeks till 37 weeks
Hospital admission for significant antepartum hemorrhage.	Number of patients requiring hospital admission for significant antepartum hemorrhage	from 26 weeks till 37 weeks
Hospital admission for threatened preterm labor.	Number of patients requiring hospital admission for threatened preterm labor	from 26 weeks till 37 weeks
Need for blood transfusion.	Number of patients requiring blood transfusion	from 26 weeks till 37 weeks
Incidence of severe postpartum hemorrhage.	Number of patients who had severe postpartum hemorrhage	from 26 weeks till 37 weeks
Incidence of Cesarean hysterectomy.	Number of patients who underwent cesarean hysterectomy	from 26 weeks till 37 weeks
Patient compliance	measured as mean number of doses of vaginal progesterone missed per week	from 26 weeks till 37 weeks
Patient satisfaction: Likert Scale	measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied.	from 26 weeks till 37 weeks
Neonatal Birth weight.	measured in Kg	At birth
Need for NICU admission and its duration.	Number of neonates needing NICU admission	At birth
Respiratory morbidity (transient tachypnea or respiratory distress syndrome).	number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).	At birth
Prematurity-related mortality.	Number of neonates dying due to prematurity-related cause	28 days postpartum

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: Progesterone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No