Clinical trial NCT03633175: Progesterone in Patients With Placenta Previa
Official title: Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Placenta Previa
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of preterm delivery due to severe antepartum hemorrhage.
timeFrame: from 26 weeks till 37 weeks
Secondary outcomes:
measure: No. of episodes of antepartum hemorrhage.
timeFrame: from 26 weeks till 37 weeks
measure: Hospital admission for significant antepartum hemorrhage.
timeFrame: from 26 weeks till 37 weeks
measure: Hospital admission for threatened preterm labor.
timeFrame: from 26 weeks till 37 weeks
measure: Need for blood transfusion.
timeFrame: from 26 weeks till 37 weeks
measure: Incidence of severe postpartum hemorrhage.
timeFrame: from 26 weeks till 37 weeks
measure: Incidence of Cesarean hysterectomy.
timeFrame: from 26 weeks till 37 weeks
measure: Patient compliance
timeFrame: from 26 weeks till 37 weeks
measure: Patient satisfaction: Likert Scale
timeFrame: from 26 weeks till 37 weeks
measure: Neonatal Birth weight.
timeFrame: At birth
measure: Need for NICU admission and its duration.
timeFrame: At birth
measure: Respiratory morbidity (transient tachypnea or respiratory distress syndrome).
timeFrame: At birth
measure: Prematurity-related mortality.
timeFrame: 28 days postpartum
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: M Samy
name: Mohamed Samy, MD
role: PRINCIPAL_INVESTIGATOR
References: