Oral Dydrogesterone in the Management of Preterm Labor

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03935152
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 3.8

Study Details

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	Intervention/Treatment	Phase
Preterm Labor	Drug: Dydrogesterone; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 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 11, 2019
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

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 [13 weeks]

   time from preterm labor to delivery

Secondary Outcome Measures

1. preterm delivery less than 34 weeks [10 weeks]

   percentage of delivery less than 34 weeks

2. preterm delivery less than 37 weeks [13 weeks]

   percentage of delivery less than 37 weeks

3. neonatal complications [13 weeks]

   percentage of newborn with RDS, IVH, NEC, death

4. side effects [13 weeks]

   percentage of side effects such as headache, nausea/vomiting

5. compliance [13 weeks]

   percentage of complete drug use

6. satisfaction [13 weeks]

   percentage of good satisfaction

7. Time to the recurrence of uterine contractions [13 weeks]

   Time to the recurrence of uterine contractions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711. Review.
• Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1:S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15. Review.
• Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
• Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80.
• Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4.

• Responsible Party: Vorapong Phupong, Professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT03935152
• Other Study ID Numbers: 286/2019
• First Posted: May 2, 2019
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature; Dydrogesterone

Study Results

No Results Posted as of Jan 22, 2021