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Completed

NCT Number: NCT03202836

Vaginal Progesterone Supplementation in the Management of Preterm Labor

This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnant women with preterm labor, gestational age 24-34 weeks

Exclusion criteria

  • have indicated preterm birth
  • allergy to progesterone
  • fetal anomalies
  • cervical dilate > 5 cm.
  • have medical disease
  • have obstetric complication

Treatment and study plan

Progesterone

Drug

vaginal utrogestan

Other names: utrogestan

Tocolytics

Drug

tocolysis for 48 hours

Steroids

Drug

antenatal corticosteroids for 48 hours

Primary outcomes

  1. Time from preterm labor pain to delivery

    Time frame: 9 weeks

    time since preterm labor to delivery

Secondary outcomes

  1. gestational age at delivery

    Time frame: 9 weeks

    gestational age at birth

  2. number of pregnant women deliver before 34 weeks

    Time frame: 6 weeks

    preterm birth < 34 weeks

  3. number of pregnant women deliver before 37 weeks

    Time frame: 9 weeks

    preterm birth < 37 weeks

  4. Number of newborn with respiratory distress syndrome

    Time frame: 9 weeks

    Number of newborn with respiratory distress syndrome

  5. Number of newborn with intraventricular hemorrhage

    Time frame: 9 weeks

    Number of newborn with intraventricular hemorrhage

  6. Number of newborn with necrotizing enterocolitis

    Time frame: 9 weeks

    Number of newborn with necrotizing enterocolitis

  7. Number of newborn with sepsis

    Time frame: 9 weeks

    Number of newborn with sepsis

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2017
Registry last updated
Jan 31, 2019

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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