Real-world evaluation of safety and effectiveness of dydrogesterone in the management of threatened abortion

Rajendra Nagarkatti, Dolly Mehra, Sudipa Mandal, Archana Dhawan, Priya Joshi, Nupur Nagarkatti, Monika Chinda, Ashok Jaiswal


Background: Threatened abortion is a relatively common complication during pregnancy. Inadequate production of endogenous progesterone is implicated as a risk factor for miscarriages. Thus, supplementation of external progesterone can be used as a preventive strategy in these women. Dydrogesterone a stereoisomer of progesterone has a good safety and tolerability profile and is known to effectively prevent pregnancy loss in women with threatened miscarriage, however, real-world data safety and effectiveness analysis of dydrogesterone in Indian patients was lacking. Therefore, this real-world retrospective analysis of the case reports was done to evaluate the safety, effectiveness, compliance, and tolerability of oral dydrogesterone in the treatment of women with threatened abortion.

Methods: Data was collected from 194 obstetricians and gynaecologists in India, on the use of oral dydrogesterone in women presenting with threatened abortion in the first trimester of pregnancy.

Results: Completed case report forms of patients who met the eligibility criteria (n = 617) were considered for the analysis. The main presenting symptom was vaginal bleeding/spotting with an additional symptom of abdominal cramp/pelvic pain/low back pain in 364 (69.07%) patients. Miscarriage was reported in 45 (7.29%) patients and 23 (3.98%) patients needed surgical intervention before 20 weeks of gestation with dydrogesterone treatment. The median time for relief of symptoms from the start of dydrogesterone tablets was 3.32 days for low back pain, 3.9 days for abdominal pain, and 4.37 days for the establishment of hemostasis. Treatment with dydrogesterone was found to be well-tolerated and adverse events were reported in 3.72% of the patients.

Conclusions: This retrospective analysis suggests that dydrogesterone is safe and effective in reducing the incidence of pregnancy loss in women with threatened abortion.


Dydrogesterone, Synthetic Progestogen, Early Pregnancy, Vaginal Bleeding, Vaginal Spotting, Threatened Miscarriage

Full Text:



Redinger A, Nguyen H. Incomplete Abortions. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2022. Available at: https://www.ncbi.nlm.nih. gov/books/NBK559071/. Accessed on 27 May 2022.

Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: Pregnancy outcome. J Steroid Biochemistry Molecular Biol. 2005;97:421-25.

Sivasane DS, Daver RG. Study of pregnancy outcome of threatened abortion and its correlation with risk factors in a tertiary care hospital of Mumbai, India. Int J Reprod Contracept Obstet Gynecol. 2018;7(11):4598-603.

Lee HJ, Park TC, Kim JH, Norwitz E, Le B. The influence of oral dydrogesterone and vaginal progesterone on threatened abortion: A systematic review and meta-analysis. Biomed Res Int. 2017;2017:3616875.

Dugas C, Slane VH. Miscarriage. [Updated 2022 May 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available at: Accessed on 2 March 2022.

Stute P. Dydrogesterone indications beyond menopausal hormone therapy: An evidence review and woman’s journey. Gynecol Endocrinol. 2021;37(8):683-8.

Arab H, Alharbi AJ, Oraif A, Sagr E, Al Madani H, Abduljabbar H, et al. The role of progestogens in threatened and idiopathic recurrent miscarriage. Int J Womens Health. 2019;11:589-96.

Griesinger G, Blockeel C, Kahler E, Fieth CP, Olofsson JI, Driessen S, et al. Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis. PLoS One. 2020;15(11):e0241044.

Lou C, Wang C, Zhao Q. Effect of dydrogesterone and progesterone on threatened miscarriage due to corpus luteum insufficiency. Am J Transl Res. 2021;13(5):4544-52.

Kumar A, Begum N, Prasad S, Aggarwal S, Sharma S. Oral dydrogesterone treatment during early pregnancy to prevent recurrent pregnancy loss and its role in modulation of cytokine production: A double-blind, randomized, parallel, placebo-controlled trial. Fertil Steril. 2014;102:1357-63.e3.

El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009;65(1):S43-S46.

Pandian RU. Dydrogesterone in threatened miscarriage: A Malaysian experience. Maturitas. 2009;65(1):S47-50.

Carp H. A systematic review of dydrogesterone for the treatment of threatened miscarriage. Gynecol Endocrinol. 2012;28(12):983-90.

Aziz N, Kallur SD, Nirmalan PK. Implications of the Revised Consensus Body Mass Indices for Asian Indians on Clinical Obstetric Practice. J Clin Diagn Res. 2014;8(5):OC01-OC03.