About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Oral Dydrogesterone in the Management of Preterm Labor

Clinicaltrials.gov identifier NCT03935152

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted July 24, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Preterm Labor
  • Intervention/Treatment: Drug: Dydrogesterone
    Drug: placebo
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: August 2022
  • Estimated Study Completion Date: October 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Dydrogesterone
dydrogesterone 10 mg by mouth every 8 hours until delivery
Drug: Dydrogesterone
dydrogesterone capsule
Placebo Comparator: Placebo
placebo by mouth every 8 hours until delivery
Drug: placebo
placebo capsule
Outcome Measures
  • Primary Outcome Measures: 1. latency period [ Time Frame: 13 weeks ]
    time from preterm labor to delivery
  • Secondary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: Vorapong Phupong, M.D. 026492115 vorapong.p@chula.ac.th

Contact: Suparudeewan Thongchan, M.D. 026492115 dewiifleur@gmail.com

Locations

Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok

Sponsors and Collaborators

Chulalongkorn University

Investigators

Study Director: Vorapong Phupong, M.D. Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

More Information