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

Aswan University Hospital

Status: Unknown

Conditions: Twin; Pregnancy, Affecting Fetus or Newborn

Treatments: Drug: progesterone 200mg; Drug: progesterone 400mg; Drug: placebo to progesterone 400mg; Drug: placebo to progesterone 200mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03781674

aswu/194/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

progesterone 400mg

Active Comparator group

Description:

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

Treatment:

Drug: progesterone 400mg

progesterone 200mg plus placebo to progesterone 200 mg

Active Comparator group

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

Treatment:

Drug: placebo to progesterone 200mg

Drug: progesterone 200mg

placebo to progesterone 400 mg

Placebo Comparator group

Description:

Women received 4 tablets placebo to vaginal progesterone suppositories

Treatment:

Drug: placebo to progesterone 200mg

Drug: placebo to progesterone 400mg