Progesterone in Patients With Placenta Previa

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Placenta Previa

Intervention / Treatment
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* Drug: Vaginal progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |