Progesterone in Patients With Placenta Previa

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633175
• Other study ID #: progesterone
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2018
• Est. completion date: August 2019

Study information

• Verified date: August 2018
• Source: Ain Shams University
• Contact: Mohamed Samy, MD
• Phone: 01001947488
• Email: mohammedsamy8132[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Previa

Intervention

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).

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No. of episodes of antepartum hemorrhage.	Mean number of episodes of antepartum hemorrhage	from 26 weeks till 37 weeks
Secondary	Hospital admission for significant antepartum hemorrhage.	Number of patients requiring hospital admission for significant antepartum hemorrhage	from 26 weeks till 37 weeks
Secondary	Hospital admission for threatened preterm labor.	Number of patients requiring hospital admission for threatened preterm labor	from 26 weeks till 37 weeks
Secondary	Need for blood transfusion.	Number of patients requiring blood transfusion	from 26 weeks till 37 weeks
Secondary	Incidence of severe postpartum hemorrhage.	Number of patients who had severe postpartum hemorrhage	from 26 weeks till 37 weeks
Secondary	Incidence of Cesarean hysterectomy.	Number of patients who underwent cesarean hysterectomy	from 26 weeks till 37 weeks
Secondary	Patient compliance	measured as mean number of doses of vaginal progesterone missed per week	from 26 weeks till 37 weeks
Secondary	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
Secondary	Neonatal Birth weight.	measured in Kg	At birth
Secondary	Need for NICU admission and its duration.	Number of neonates needing NICU admission	At birth
Secondary	Respiratory morbidity (transient tachypnea or respiratory distress syndrome).	number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).	At birth
Secondary	Prematurity-related mortality.	Number of neonates dying due to prematurity-related cause	28 days postpartum