Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

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

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.

Study Overview

• Status: Completed
• Conditions: Threatened Abortion
• Intervention / Treatment: Drug: Placebo; Drug: Dydrogesterone

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vorapong Phupong, M.D.; Phone Number: +6626492115; Email: vorapong.p@chula.ac.th
• Study Contact Backup: Name: Arissara Kuptarak, M.D.; Phone Number: +6626492115; Email: arissaramd@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dydrogesterone; dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.	Drug: Dydrogesterone; Dydrogesterone tablet
Placebo Comparator: Placebo; placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.	Drug: Placebo; Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continue pregnancy more than 20 weeks gestation	percentage of cases with continue pregnancy more than 20 weeks gestation	at 20 weeks gestation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Director: Vorapong Phupong, M.D., Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: threatened abortion
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Spontaneous; Abortion, Threatened; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: 177/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No