Oral Dydrogesterone in the Management of Preterm Labor

NCT03935152 | Completed Phase 4 DMC

• 1 other identifier: 286/2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• latency period

  time from preterm labor to delivery

  13 weeks

Secondary Outcomes (7)

• preterm delivery less than 34 weeks

  10 weeks

• preterm delivery less than 37 weeks

  13 weeks

• neonatal complications

  13 weeks

• side effects

  13 weeks

• compliance

  13 weeks

Study Arms (2)

Dydrogesterone

ACTIVE COMPARATOR

dydrogesterone 10 mg by mouth every 8 hours until delivery

Drug: Dydrogesterone

Placebo

PLACEBO COMPARATOR

placebo by mouth every 8 hours until delivery

Drug: placebo

Interventions

Dydrogesterone DRUG

dydrogesterone capsule

Dydrogesterone

placebo DRUG

placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (10)

• 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.

  PMID: 27661654 BACKGROUND

• 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(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.

  PMID: 24625129 BACKGROUND

• Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.

  PMID: 22102929 BACKGROUND

• 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.

  PMID: 29981319 BACKGROUND

• 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. doi: 10.1016/j.maturitas.2008.11.013.

  PMID: 19434889 BACKGROUND

• Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2008 Feb;48(1):58-63. doi: 10.1111/j.1479-828X.2007.00803.x.

  PMID: 18275573 RESULT

• Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73. doi: 10.1159/000328719. Epub 2011 Nov 12.

  PMID: 22086108 RESULT

• Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3.

  PMID: 24807871 RESULT

• Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638.

  PMID: 26856618 RESULT

• Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6.

  PMID: 33509129 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Vorapong Phupong, M.D.

  Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: May 11, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

TH (1)