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17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
17-OHPC
placebo to 17-OHPC
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring cesarean section, placenta previa, antepartum hemorrhage, 17-alpha-Hydroxyprogesterone caproate

Eligibility Criteria

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

Inclusion Criteria:

  • Estimated gestational age: between 24 weeks and 37 week's gestation
  • Confirmed Placenta previa; either major or minor degrees.
  • Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding

Exclusion Criteria:

  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non-reassuring tracing
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae
  • Patients with known bleeding disorders or on anticoagulant therapy
  • Patients with severe medical disorders

Sites / Locations

  • Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

17-OHPC

placebo to 17-OHPC

Arm Description

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Outcomes

Primary Outcome Measures

the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery

Secondary Outcome Measures

apgar score
measure apgar score from 0 to 10
the number of patients with postpartum hemorrhage
calculation the number of patients with postpartum hemorrhage

Full Information

First Posted
December 15, 2018
Last Updated
February 14, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03779438
Brief Title
17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa
Official Title
Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic 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
March 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa
Detailed Description
Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth. Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa. The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

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, 17-alpha-Hydroxyprogesterone caproate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Double-Blind Randomized Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A Double-Blind Randomized Clinical Trial
Allocation
Randomized
Enrollment
300 (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 24-26 week and up to 37-weeks' gestation or delivery
Arm Title
placebo to 17-OHPC
Arm Type
Placebo Comparator
Arm Description
patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Intervention Type
Drug
Intervention Name(s)
17-OHPC
Other Intervention Name(s)
Active Comparator, cidolut depot
Intervention Description
patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Intervention Type
Drug
Intervention Name(s)
placebo to 17-OHPC
Other Intervention Name(s)
Placebo Comparator
Intervention Description
patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Primary Outcome Measure Information:
Title
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
Description
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
apgar score
Description
measure apgar score from 0 to 10
Time Frame
5 minutes postpartum
Title
the number of patients with postpartum hemorrhage
Description
calculation the number of patients with postpartum hemorrhage
Time Frame
24 hours post operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women with symptomatic placenta previa
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Estimated gestational age: between 24 weeks and 37 week's gestation Confirmed Placenta previa; either major or minor degrees. Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding Exclusion Criteria: Severe attack of bleeding requiring an immediate intervention. Fetal heart rates instability or non-reassuring tracing Intrauterine fetal death or major fetal anomalies. If associated with abruptio placentae Patients with known bleeding disorders or on anticoagulant therapy Patients with severe medical disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam
Phone
01022336052
Ext
002
Email
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
Email
nahla.elsayed@aswu.ed.eg
First Name & Middle Initial & Last Name & Degree
Nahla w Shady, md
Phone
1019240504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

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