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Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Primary Purpose

Placenta Previa

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

17-OHPC

vaginal progesterone

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Gestational age 26-28 weeks of gestation.
Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan

Exclusion Criteria:

Multiple pregnancies.
Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour 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.

Sites / Locations

Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

17-OHPC

vaginal progesterone

control group

Arm Description

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

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

Outcomes

Primary Outcome Measures

number of patient delivered before 37 weeks

calculation the number of patients delivered before 37 weeks

Secondary Outcome Measures

number of episodes of antepartum hemorrhage

calculating the mean number of episodes of antepartum hemorrhage

Hospital admission for significant antepartum hemorrhage

Number of patients requiring hospital admission for significant antepartum hemorrhage

Neonatal Birth weight

measure Neonatal Birth weight in kilograms

Full Information

NCT ID

NCT03779451

First Posted

December 15, 2018

Last Updated

February 14, 2019

Sponsor

Aswan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03779451

Brief Title

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Official Title

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

Detailed Description

The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.

6. Conditions and Keywords

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

Placenta Previa

Keywords

cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized controlled study

Masking

None (Open Label)

Masking Description

An open-label randomized controlled study

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

17-OHPC

Arm Type

Active Comparator

Arm Description

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery

Arm Title

vaginal progesterone

Arm Type

Active Comparator

Arm Description

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

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)

17-OHPC

Other Intervention Name(s)

Active Comparator, cidolut depot

Intervention Description

received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.

Intervention Type

Drug

Intervention Name(s)

vaginal progesterone

Other Intervention Name(s)

Active Comparator, Cyclogest

Intervention Description

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

Primary Outcome Measure Information:

Title

number of patient delivered before 37 weeks

Description

calculation the number of patients delivered before 37 weeks

Time Frame

2 month

Secondary Outcome Measure Information:

Title

number of episodes of antepartum hemorrhage

Description

calculating the mean number of episodes of antepartum hemorrhage

Time Frame

2 month

Title

Hospital admission for significant antepartum hemorrhage

Description

Number of patients requiring hospital admission for significant antepartum hemorrhage

Time Frame

2 month

Title

Neonatal Birth weight

Description

measure Neonatal Birth weight in kilograms

Time Frame

one hours post operative

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

pregnant women with placenta previa

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gestational age 26-28 weeks of gestation. Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan Exclusion Criteria: Multiple pregnancies. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour 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

hany f sallam, md

Phone

01022336052

Ext

002

hany.farouk@aswu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hany f sallam, md

Organizational Affiliation

Aswan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aswan University

City

Aswan

ZIP/Postal Code

81528

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hany f sallam, md

Phone

01092440504

Ext

002

nahla.elsayed@aswu.ed.eg

First Name & Middle Initial & Last Name & Degree

Nahla w Shady, md

Phone

1019240504

Ext

002

nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

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