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

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ClinicalTrials.gov Identifier: NCT03781674
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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.

Condition or disease Intervention/treatment Phase
Twin; Pregnancy, Affecting Fetus or Newborn Drug: progesterone 400mg Drug: progesterone 200mg Drug: placebo to progesterone 200mg Drug: placebo to progesterone 400mg Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a double‐blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: a double‐blind randomized controlled trial
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: progesterone 400mg
Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age
Drug: progesterone 400mg
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
Other Name: Active Comparator

Active Comparator: progesterone 200mg plus placebo to progesterone 200 mg
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
Drug: progesterone 200mg
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
Other Name: Active Comparator

Drug: placebo to progesterone 200mg
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
Other Name: Placebo comparator

Placebo Comparator: placebo to progesterone 400 mg
Women received 4 tablets placebo to vaginal progesterone suppositories
Drug: placebo to progesterone 200mg
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
Other Name: Placebo comparator

Drug: placebo to progesterone 400mg
Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
Other Name: placebo comparator




Primary Outcome Measures :
  1. Preterm labor before 34 weeks gestations [ Time Frame: Up to 34 weeks gestational age ]
    Number of patients delivered before 34 weeks gestations


Secondary Outcome Measures :
  1. Neonatal respiratory distress syndrome [ Time Frame: At birth ]
    Number of neonates develop respiratory distress syndrome


Other Outcome Measures:
  1. Early neonatal death [ Time Frame: One month after birth ]
    number of neonates died within one month from birth



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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:   Women pregnant in dichorionic twins.
Accepts Healthy Volunteers:   No
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.

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): NCT03781674


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: NCT03781674     History of Changes
Other Study ID Numbers: aswu/194/18
First Posted: December 20, 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:
Preterm birth
Twin gestation
Vaginal progesterone

Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs