Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Phase 2

Completed

• Conditions: Preterm Birth
• Interventions: Drug: The progesterone vaginal pessary; Drug: Tonics group

• Registration Number: NCT02350231
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-25
• Study First Posted: 2015-01-29
• Status Verified: 2017-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-15
• Last Update Submitted: 2017-01-21
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The progesterone vaginal pessary group	The progesterone vaginal pessary	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
Tonics group	Tonics group	Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery

Primary Outcome Measures

Name	Time	Method
Time of delivery	from 28 weeks till delivery

Secondary Outcome Measures

Name	Time	Method
Mode of delivery	from 28 weeks till delivery
Birth weight	at time of delivery
The need for neonatal intensive care incubator.	after delivery