Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

NCT02350231 | Completed Phase 2 DMC

• 1 other identifier: Progesterone vaginal pessary
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

preterm birth; Twin pregnancy; progesterone

Outcome Measures

Primary Outcomes (1)

• Time of delivery

  from 28 weeks till delivery

Secondary Outcomes (3)

• Mode of delivery

  from 28 weeks till delivery

• Birth weight

  at time of delivery

• The need for neonatal intensive care incubator.

  after delivery

Study Arms (2)

The progesterone vaginal pessary group

ACTIVE COMPARATOR

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

Drug: The progesterone vaginal pessary

Tonics group

PLACEBO COMPARATOR

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

Drug: Tonics group

Interventions

The progesterone vaginal pessary DRUG

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

Also known as: Active drug treatment

The progesterone vaginal pessary group

Tonics group DRUG

Those patients will receive only tonics

Also known as: Placepo

Tonics group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diamniotic twin pregnancy
• Gestational age ± 28 weeks.

You may not qualify if:

• Higher multiple pregnancy
• IUFD of one or both fetuses
• Any congenital anomalies
• IUGR or discordant twins
• PROM
• If there is any contraindication to progesterone treatment
• Women who did performed cervical cerclage in the current pregnancy
• Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).
• Threatened preterm labor.
• Polyhydromnis.
• Other medical disorder with pregnancy

Sponsors & Collaborators

• Assiut University: lead
• Sohag University: collaborator

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 29, 2015
• Study Start: February 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 15, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01