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

Twin; Pregnancy, Affecting Fetus or Newborn Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781674
• Other study ID #: aswu/194/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Twin; Pregnancy, Affecting Fetus or Newborn

Intervention

Drug:
• progesterone 400mg
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
• progesterone 200mg
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
• 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
• 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

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Early neonatal death	number of neonates died within one month from birth	One month after birth
Primary	Preterm labor before 34 weeks gestations	Number of patients delivered before 34 weeks gestations	Up to 34 weeks gestational age
Secondary	Neonatal respiratory distress syndrome	Number of neonates develop respiratory distress syndrome	At birth