Clinical trial NCT04788108: Oral Progesterone for Prevention of Miscarriage in Threatened Abortion
Official title: Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Threatened Abortion
Keywords: threatened abortion
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy with gestational age 6 - 20 weeks
* threatened abortion
* confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion Criteria:

* history of recurrent miscarriage
* having endocervical polyp
* having infection such as pneumonia, pyelonephritis, septicemia
* having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
* having cancer
* having coagulation defect
* allergy to dydrogesterone

Primary outcomes:
measure: continue pregnancy more than 20 weeks gestation
timeFrame: at 20 weeks gestation
Secondary outcomes:
measure: preterm delivery less than 34 weeks
timeFrame: at 34 weeks gestation
measure: preterm delivery less than 37 weeks
timeFrame: at 37 weeks gestation
measure: placenta previa
timeFrame: 31 weeks
measure: abruptio placenta
timeFrame: 31 weeks
measure: Intrauterine growth restriction
timeFrame: 31 weeks
measure: neonatal complications
timeFrame: 31 weeks
measure: side effects
timeFrame: 6 weeks
measure: compliance
timeFrame: 6 weeks
measure: maternal satisfaction
timeFrame: 6 weeks
measure: time until bleeding stops
timeFrame: 6 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-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
citation: Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.
citation: Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014.
citation: Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.
citation: Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14.
citation: El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14.