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

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

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.

Study Overview

• Status: Unknown
• Conditions: Twin; Pregnancy, Affecting Fetus or Newborn
• Intervention / Treatment: Drug: progesterone 400mg; Drug: progesterone 200mg; Drug: placebo to progesterone 200mg; Drug: placebo to progesterone 400mg

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm labor before 34 weeks gestations	Number of patients delivered before 34 weeks gestations	Up to 34 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal respiratory distress syndrome	Number of neonates develop respiratory distress syndrome	At birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early neonatal death	number of neonates died within one month from birth	One month after birth

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Preterm birth; Twin gestation; Vaginal progesterone
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: aswu/194/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No