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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaginal Progesterone in Twin With Short Cervix

NCT02697331

Preterm Birth Twin Dichorionic Diamniotic Placenta

COMPLETED PHASE3

Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

NCT03781466

Twin; Pregnancy, Affecting Fetus or Newborn

UNKNOWN NA

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

NCT03781674

Twin; Pregnancy, Affecting Fetus or Newborn

UNKNOWN NA

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

NCT04748562

Twin Pregnancy With Antenatal Problem

COMPLETED PHASE4

Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix

NCT02329535

Premature Birth

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Labour

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progesterone group

Women received vaginal progesterone suppositories

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age

No treatment group

Women received no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progesterone

Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyclogest

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No