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Completed

NCT Number: NCT03935152

Oral Dydrogesterone in the Management of Preterm Labor

This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.

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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

Phase 4

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 with gestational age 24-33 weeks 6 days
  • preterm labor
  • received treatment with tocolysis and corticosteroids

Exclusion criteria

  • conditions that need immediate delivery such as fetal distress, chorioamnionitis
  • have medical complications such as heart disease, seizure
  • fetal anomalies
  • cervical dilatation more than 5 cm
  • allergy to dydrogesterone

Treatment and study plan

Dydrogesterone

Drug

dydrogesterone capsule

Placebo

Drug

placebo capsule

Primary outcomes

  1. latency period

    Time frame: 13 weeks

    time from preterm labor to delivery

Secondary outcomes

  1. preterm delivery less than 34 weeks

    Time frame: 10 weeks

    percentage of delivery less than 34 weeks

  2. preterm delivery less than 37 weeks

    Time frame: 13 weeks

    percentage of delivery less than 37 weeks

  3. neonatal complications

    Time frame: 13 weeks

    percentage of newborn with RDS, IVH, NEC, death

  4. side effects

    Time frame: 13 weeks

    percentage of side effects such as headache, nausea/vomiting

  5. compliance

    Time frame: 13 weeks

    percentage of complete drug use

  6. satisfaction

    Time frame: 13 weeks

    percentage of good satisfaction

  7. Time to the recurrence of uterine contractions

    Time frame: 13 weeks

    Time to the recurrence of uterine contractions

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 2, 2019
Registry last updated
Jan 22, 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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