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Completed

NCT Number: NCT02262481

Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

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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

15 year–40 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 pregnancy
  • Preterm labor
  • GA24-34wk
  • Intact membranes

Exclusion criteria

  • Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
  • Placenta previa
  • medical and obstetric complications
  • allergy to dydrogesterone

Treatment and study plan

Dydrogesterone

Drug

Other names: Duphaston

Placebo

Drug

Primary outcomes

  1. The recurrence of uterine contraction within 48 hours after stop tocolytic

    Time frame: 48 hours

Secondary outcomes

  1. Time from preterm labor pain to delivery

    Time frame: 9 weeks

  2. Gestational age at delivery

    Time frame: 9 weeks

  3. Number of newborn with respiratory distress syndrome

    Time frame: 9 weeks

  4. side effects

    Time frame: 9 weeks

  5. Number of newborn with intraventricular hemorrhage

    Time frame: 9 weeks

  6. Number of newborn with necrotizing enterocolitis

    Time frame: 9 weeks

  7. Number of newborn with sepsis

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 13, 2014
Registry last updated
Jan 28, 2016

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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