Progesterone in Patients With Placenta Previa

Phase 2

• Conditions: Placenta Previa
• Interventions: Drug: Vaginal progesterone

• Registration Number: NCT03633175
• Lead Sponsor: Ain Shams University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-30
• Study Start: 2018-07-05
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-16
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 74

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone group	Vaginal progesterone	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).

Primary Outcome Measures

Name	Time	Method
Incidence of preterm delivery due to severe antepartum hemorrhage.	from 26 weeks till 37 weeks	Number of patients who delivered before 37 weeks gestational age

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain SHams Maternity Hospital; 🇪🇬 Cairo, Abbaseya, Egypt