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Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02350231
Acronym
PPPTP
Enrollment
100
Registered
2015-01-29
Start date
2014-02-01
Completion date
2017-01-15
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

preterm birth, Twin pregnancy, progesterone

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.

Interventions

DRUGThe progesterone vaginal pessary

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

DRUGTonics group

Those patients will receive only tonics

Sponsors

Sohag University
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time of deliveryfrom 28 weeks till delivery

Secondary

MeasureTime frame
Mode of deliveryfrom 28 weeks till delivery
Birth weightat time of delivery
The need for neonatal intensive care incubator.after delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026