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Progesterone in Patients With Placenta Previa

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vaginal progesterone
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain SHams Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Vaginal progesterone group

Control group

Arm Description

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).

Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.

Outcomes

Primary Outcome Measures

Incidence of preterm delivery due to severe antepartum hemorrhage.
Number of patients who delivered before 37 weeks gestational age

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2016
Last Updated
August 15, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03633175
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaginal progesterone group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone
Other Intervention Name(s)
Prontogest® suppositories
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of preterm delivery due to severe antepartum hemorrhage.
Description
Number of patients who delivered before 37 weeks gestational age
Time Frame
from 26 weeks till 37 weeks
Secondary Outcome Measure Information:
Title
No. of episodes of antepartum hemorrhage.
Description
Mean number of episodes of antepartum hemorrhage
Time Frame
from 26 weeks till 37 weeks
Title
Hospital admission for significant antepartum hemorrhage.
Description
Number of patients requiring hospital admission for significant antepartum hemorrhage
Time Frame
from 26 weeks till 37 weeks
Title
Hospital admission for threatened preterm labor.
Description
Number of patients requiring hospital admission for threatened preterm labor
Time Frame
from 26 weeks till 37 weeks
Title
Need for blood transfusion.
Description
Number of patients requiring blood transfusion
Time Frame
from 26 weeks till 37 weeks
Title
Incidence of severe postpartum hemorrhage.
Description
Number of patients who had severe postpartum hemorrhage
Time Frame
from 26 weeks till 37 weeks
Title
Incidence of Cesarean hysterectomy.
Description
Number of patients who underwent cesarean hysterectomy
Time Frame
from 26 weeks till 37 weeks
Title
Patient compliance
Description
measured as mean number of doses of vaginal progesterone missed per week
Time Frame
from 26 weeks till 37 weeks
Title
Patient satisfaction: Likert Scale
Description
measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied.
Time Frame
from 26 weeks till 37 weeks
Title
Neonatal Birth weight.
Description
measured in Kg
Time Frame
At birth
Title
Need for NICU admission and its duration.
Description
Number of neonates needing NICU admission
Time Frame
At birth
Title
Respiratory morbidity (transient tachypnea or respiratory distress syndrome).
Description
number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).
Time Frame
At birth
Title
Prematurity-related mortality.
Description
Number of neonates dying due to prematurity-related cause
Time Frame
28 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Samy, MD
Phone
01001947488
Email
mohammedsamy8132@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Samy, MD
Organizational Affiliation
M Samy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Samy, MD
Phone
01001947488
Email
mohammedsamy8132@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Progesterone in Patients With Placenta Previa

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