Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Threatened Abortion Clinical Trial

Official title:

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788108
• Other study ID #: 177/2021
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortion, Threatened
• Threatened Abortion

Intervention

Drug:
• Dydrogesterone
Dydrogesterone tablet
• Placebo
Placebo tablet

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 (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	continue pregnancy more than 20 weeks gestation	percentage of cases with continue pregnancy more than 20 weeks gestation	at 20 weeks gestation
Secondary	preterm delivery less than 34 weeks	percentage of delivery less than 34 weeks	at 34 weeks gestation
Secondary	preterm delivery less than 37 weeks	percentage of delivery less than 37 weeks	at 37 weeks gestation
Secondary	placenta previa	percentage of placenta previa	31 weeks
Secondary	abruptio placenta	percentage of abruptio placenta	31 weeks
Secondary	Intrauterine growth restriction	percentage of intrauterine growth restriction	31 weeks
Secondary	neonatal complications	percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death	31 weeks
Secondary	side effects	percentage of side effects such as headache, nausea/vomiting	6 weeks
Secondary	compliance	percentage of complete drug use	6 weeks
Secondary	maternal satisfaction	percentage of good satisfaction	6 weeks
Secondary	time until bleeding stops	time from first bleeding until bleeding stops	6 weeks