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Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

Primary Purpose

Twin; Pregnancy, Affecting Fetus or Newborn

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
progesterone 400mg
progesterone 200mg
placebo to progesterone 200mg
placebo to progesterone 400mg
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Twin; Pregnancy, Affecting Fetus or Newborn focused on measuring Preterm birth, Twin gestation, Vaginal progesterone

Eligibility Criteria

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

Inclusion Criteria:

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in the current pregnancy.
  • Cervical cerclage in the current pregnancy.
  • Medical conditions that may lead to preterm delivery.
  • Rupture of membranes.
  • Vaginal bleeding.

Sites / Locations

  • Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

progesterone 400mg

progesterone 200mg plus placebo to progesterone 200 mg

placebo to progesterone 400 mg

Arm Description

Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age

Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone

Women received 4 tablets placebo to vaginal progesterone suppositories

Outcomes

Primary Outcome Measures

Preterm labor before 34 weeks gestations
Number of patients delivered before 34 weeks gestations

Secondary Outcome Measures

Neonatal respiratory distress syndrome
Number of neonates develop respiratory distress syndrome

Full Information

First Posted
December 18, 2018
Last Updated
February 14, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03781674
Brief Title
Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation
Official Title
Evaluation of the Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: a Double-Blind Randomized Controlled Trial
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
No

5. Study Description

Brief Summary
The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Detailed Description
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin; Pregnancy, Affecting Fetus or Newborn
Keywords
Preterm birth, Twin gestation, Vaginal progesterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a double-blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
a double-blind randomized controlled trial
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
progesterone 400mg
Arm Type
Active Comparator
Arm Description
Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age
Arm Title
progesterone 200mg plus placebo to progesterone 200 mg
Arm Type
Active Comparator
Arm Description
Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone
Arm Title
placebo to progesterone 400 mg
Arm Type
Placebo Comparator
Arm Description
Women received 4 tablets placebo to vaginal progesterone suppositories
Intervention Type
Drug
Intervention Name(s)
progesterone 400mg
Other Intervention Name(s)
Active Comparator
Intervention Description
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
Intervention Type
Drug
Intervention Name(s)
progesterone 200mg
Other Intervention Name(s)
Active Comparator
Intervention Description
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
Intervention Type
Drug
Intervention Name(s)
placebo to progesterone 200mg
Other Intervention Name(s)
Placebo comparator
Intervention Description
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
Intervention Type
Drug
Intervention Name(s)
placebo to progesterone 400mg
Other Intervention Name(s)
placebo comparator
Intervention Description
Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
Primary Outcome Measure Information:
Title
Preterm labor before 34 weeks gestations
Description
Number of patients delivered before 34 weeks gestations
Time Frame
Up to 34 weeks gestational age
Secondary Outcome Measure Information:
Title
Neonatal respiratory distress syndrome
Description
Number of neonates develop respiratory distress syndrome
Time Frame
At birth
Other Pre-specified Outcome Measures:
Title
Early neonatal death
Description
number of neonates died within one month from birth
Time Frame
One month after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women pregnant in dichorionic twins.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women pregnant in dichorionic twins. Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age. No symptoms, signs or other risk factors for preterm labor. Exclusion Criteria: Known allergy or contraindication (relative or absolute) to progesterone therapy. Monochorionic twins. Known major fetal structural or chromosomal abnormality. Intrauterine death of one fetus or death of both fetuses. Fetal reduction in the current pregnancy. Cervical cerclage in the current pregnancy. Medical conditions that may lead to preterm delivery. Rupture of membranes. Vaginal bleeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
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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Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

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