Clinical trial NCT03935152: Oral Dydrogesterone in the Management of Preterm Labor
Official title: Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Labor
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: latency period
timeFrame: 13 weeks
Secondary outcomes:
measure: preterm delivery less than 34 weeks
timeFrame: 10 weeks
measure: preterm delivery less than 37 weeks
timeFrame: 13 weeks
measure: neonatal complications
timeFrame: 13 weeks
measure: side effects
timeFrame: 13 weeks
measure: compliance
timeFrame: 13 weeks
measure: satisfaction
timeFrame: 13 weeks
measure: Time to the recurrence of uterine contractions
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
name: Vorapong Phupong, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
citation: Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
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.
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. doi: 10.1016/j.maturitas.2008.11.013.
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.
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.
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 2014 Apr 3.
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.
citation: 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.