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NCT Number: NCT04748562

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy.

There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies

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Key information

Conditions

Twin Pregnancy With Antenatal Problem Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Maternity hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primigravidae
  • Twin pregnancies at gestational age 14 week.
  • Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)

Exclusion criteria

  • Polyhydramnios
  • Anemia
  • Twins with congenital malformation
  • Twin to twin transfusion
  • Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
  • Previous cervical surgery
  • High order pregnancy (triples or more)

Treatment and study plan

Progesterone

Drug

Taking prontogest vaginally

Primary outcomes

  1. Preterm labor

    Time frame: Before 37 weeks gestation

    Number of participants which had preterm labor

Secondary outcomes

  1. Cervical length changes

    Time frame: Between 14 weeks and 22 weeks gestation

    Cervical length changes in centimeters

  2. Neonatal ICU admission

    Time frame: The first 28 days after delivery

    Number of neonates required neonatal ICU admission

  3. Neonatal mechanical ventilation

    Time frame: The first 28 days after delivery

    Number of neonates required mechanical ventilation

  4. Progesterone side effects

    Time frame: During one year which is the period from the start of the study till its end

    The number of patients experiencing progesterone side effects

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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