Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Preterm Birth Clinical Trial

— PPPTP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350231
• Other study ID #: Progesterone vaginal pessary
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 5, 2015
• Last updated: January 21, 2017
• Start date: February 1, 2014
• Est. completion date: January 15, 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• The progesterone vaginal pessary
Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
• Tonics group
Those patients will receive only tonics

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of delivery		from 28 weeks till delivery
Secondary	Mode of delivery		from 28 weeks till delivery
Secondary	Birth weight		at time of delivery
Secondary	The need for neonatal intensive care incubator.		after delivery