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Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

M

Mohamed Sayed Abdelhafez

Status and phase

Completed
Phase 4

Conditions

Premature Labour

Treatments

Drug: Progesterone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Full description

Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Enrollment

182 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

Exclusion criteria

  • Age < 20 years or > 35 years.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in current pregnancy.
  • Cervical cerclage in 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

None (Open label)

182 participants in 2 patient groups

Progesterone group
Active Comparator group
Description:
Women received vaginal progesterone suppositories
Treatment:
Drug: Progesterone
No treatment group
No Intervention group
Description:
Women received no treatment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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