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

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ClinicalTrials.gov Identifier: NCT03779451
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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

Condition or disease Intervention/treatment Phase
Placenta Previa Drug: 17-OHPC Drug: vaginal progesterone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled study
Masking: None (Open Label)
Masking Description: An open-label randomized controlled study
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 1, 2022


Arm Intervention/treatment
Active Comparator: 17-OHPC
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
Drug: 17-OHPC
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.
Other Names:
  • Active Comparator
  • cidolut depot

Active Comparator: vaginal progesterone
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
Drug: vaginal progesterone
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
Other Names:
  • Active Comparator
  • Cyclogest

No Intervention: control group
Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.



Primary Outcome Measures :
  1. number of patient delivered before 37 weeks [ Time Frame: 2 month ]
    calculation the number of patients delivered before 37 weeks


Secondary Outcome Measures :
  1. number of episodes of antepartum hemorrhage [ Time Frame: 2 month ]
    calculating the mean number of episodes of antepartum hemorrhage

  2. Hospital admission for significant antepartum hemorrhage [ Time Frame: 2 month ]
    Number of patients requiring hospital admission for significant antepartum hemorrhage

  3. Neonatal Birth weight [ Time Frame: one hours post operative ]
    measure Neonatal Birth weight in kilograms



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women with placenta previa
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779451


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, md    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03779451     History of Changes
Other Study ID Numbers: aswu/191/18
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
cesarean section
placenta previa
antepartum hemorrhage
vaginal progesterone
17-Alpha-Hydroxyprogesterone Caproate

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists