Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

NCT ID: NCT02350231

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-01
• Study Completion Date: 2017-01-15

Brief Summary

Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.

Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.

Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.

Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.

Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The progesterone vaginal pessary group

Where they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium

Group Type: ACTIVE_COMPARATOR

The progesterone vaginal pessary

Intervention Type: DRUG

Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy

Tonics group

Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery

Group Type: PLACEBO_COMPARATOR

Tonics group

Intervention Type: DRUG

Those patients will receive only tonics

Interventions

The progesterone vaginal pessary

Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy

Intervention Type: DRUG

Tonics group

Those patients will receive only tonics

Intervention Type: DRUG

Other Intervention Names

Active drug treatment; Placepo

Eligibility Criteria

Inclusion Criteria

1. Diamniotic twin pregnancy

2. Gestational age ± 28 weeks.

Exclusion Criteria

1. Higher multiple pregnancy

2. IUFD of one or both fetuses

3. Any congenital anomalies

4. IUGR or discordant twins

5. PROM

6. If there is any contraindication to progesterone treatment

7. Women who did performed cervical cerclage in the current pregnancy

8. Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).

9. Threatened preterm labor.

10. Polyhydromnis.

11. Other medical disorder with pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mamdouh Shaaban

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Progesterone vaginal pessary

Identifier Type: -

Identifier Source: org_study_id