Oral Dydrogesterone in the Management of Preterm Labor

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935152
• Other study ID #: 286/2019
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: January 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• Dydrogesterone
dydrogesterone capsule
• placebo
placebo capsule

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	latency period	time from preterm labor to delivery	13 weeks
Secondary	preterm delivery less than 34 weeks	percentage of delivery less than 34 weeks	10 weeks
Secondary	preterm delivery less than 37 weeks	percentage of delivery less than 37 weeks	13 weeks
Secondary	neonatal complications	percentage of newborn with RDS, IVH, NEC, death	13 weeks
Secondary	side effects	percentage of side effects such as headache, nausea/vomiting	13 weeks
Secondary	compliance	percentage of complete drug use	13 weeks
Secondary	satisfaction	percentage of good satisfaction	13 weeks
Secondary	Time to the recurrence of uterine contractions	Time to the recurrence of uterine contractions	13 weeks