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Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth (PPPTP)

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ClinicalTrials.gov Identifier: NCT02350231
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Sohag University
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, 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.


Condition or disease Intervention/treatment Phase
Preterm Birth Drug: The progesterone vaginal pessary Drug: Tonics group Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: The progesterone vaginal pessary
Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
Other Name: Active drug treatment

Placebo Comparator: Tonics group
Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery
Drug: Tonics group
Those patients will receive only tonics
Other Name: Placepo




Primary Outcome Measures :
  1. Time of delivery [ Time Frame: from 28 weeks till delivery ]

Secondary Outcome Measures :
  1. Mode of delivery [ Time Frame: from 28 weeks till delivery ]
  2. Birth weight [ Time Frame: at time of delivery ]
  3. The need for neonatal intensive care incubator. [ Time Frame: after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Responsible Party: Omar Mamdouh Shaaban, Professor of Obstetrics and Gynecology, Assiut University
ClinicalTrials.gov Identifier: NCT02350231    
Other Study ID Numbers: Progesterone vaginal pessary
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Omar Mamdouh Shaaban, Assiut University:
preterm birth
Twin pregnancy
progesterone
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs