Abstract
Objective
To investigate the efficacy, safety and tolerability of a home-based extended low-dose oral misoprostol for management of first-trimester pregnancy loss.
Materials and Methods
A randomized trial that was conducted in the Woman’s Health University Hospital and El-eman Maternity Hospital, Assiut, Egypt. One hundred and sixty patients were included. They were randomly assigned to receive four tablets of 200 μg misoprostol vaginally (max. 800 μg-hospital group) or 12 tablets orally, one every 3 h, over 2 consecutive days (max. 2400 μg-extended low-dose home group). For failed first dose, another similar second dose was given. Primary outcome measure was the percentage of patients with ‘medically completed miscarriages’ in each group (including complete miscarriages + incomplete miscarriages with successful post-miscarriage misoprostol).
Results
The total number of patients with ‘medically completed miscarriages’ in home group was 65/79 (82.3%), which was comparable to the hospital group (52/71 or 73.2%) (P = 0.182). However, the majority of patients in home group had significantly successful miscarriages after a single course of low-dose oral misoprostol, experienced much less heavy bleeding attacks and had less systemic side effects.
Conclusion
In low-resource communities, the home-based extended low-dose oral misoprostol protocol proved high efficacy, safety and tolerability in management of first-trimester pregnancy loss.
Similar content being viewed by others
References
National Institute for Health and Care Excellence (NICE). Ectopic pregnancy and miscarriage: diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage (CG154). London: NICE. 2012. https://www.nice.org.uk/guidance/CG154/chapter/1-Recommendations#management-of-miscarriage. Accessed 11 Nov 2018.
Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynecol Obstet. 2007;99(Suppl 2):S160–7.
Morris JL, Winikoff B, Dabash R, et al. FIGO’s updated recommendations for misoprostol used alone in gynecology and obstetrics. Int J Gynecol Obstet. 2017;138(3):363–6.
FIGO Guideline: Misoprostol Recommended Dosages 2012. https://www.figo.org/sites/default/files/uploads/project-publications/Miso/Misoprostol_Recommended%20Dosages%202012.pdf. Accessed 17 Jan 2017.
Tang OS, Schweer H, Seyberth HW, et al. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002;17:332–6.
Saraswat L, Ashok PW, Mathur M. Medical management of miscarriage. Obstet Gynaecol. 2014;16:79–85.
Wu HL, Marwah S, Wang P, et al. Misoprostol for medical treatment of missed abortion: a systematic review and network meta-analysis. Sci Rep. 2017;7(1):1664.
Metwaly AB, Abbas AM, Al-Sakkaf M. The use of single dose of oral misoprostol (600 µg) at home in management of first trimester miscarriages in El-Mukala, Yemen. Int J Reprod Contracept Obstet Gynecol. 2017;5(5):1360–3.
Benchamanon R, Phupong V. Effectiveness of a single dose of oral misoprostol 600 μg for treatment in early pregnancy failure. J Obstet Gynaecol. 2014;34:726–9.
Gupta S, Sharma R, Rizvi S. Study on use of oral misoprostol for medical evacuation of missed abortion. Int J Sci Res. 2017;6(10):604–5.
Nazir Q, Habib S, Sultana R, et al. Success and safety of misoprostol for treatment of early pregnancy failure. J Ayub Med Coll Abbottabad. 2018;30(2):245–7.
Marwah S, Gupta S, Batra NP, et al. A comparative study to evaluate the efficacy of vaginal vs oral prostaglandin E1 analogue (misoprostol) in management of first trimester missed abortion. J Clin Diagn Res JCDR. 2016;10(5):QC14.
Tang OS, Schweer H, Lee SW, et al. Pharmacokinetics of repeated doses of misoprostol. Hum Reprod. 2009;24:1862–9.
Arain RF, Arain RF. Use of misoprostol in missed abortion—a double edged sword in anemia prevailing countries. IOSR J Dent Med Sci (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861. Volume 16, Issue 3 Ver. VI; 2017. p. 100–103.
Zhang J, Gilles JM, Barnhart K, et al. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005;353:761–9.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
All authors declare that they have no conflict of interest.
Ethical Approval
Obtained approval of the ethical review committees of the department of Obstetrics and Gynecology and Assiut College of Medicine.
Informed Consent
Informed consent was obtained.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Dr. Ayman H. Shaamash, Professor at the Department of Obstetrics and Gynecology, Consultant at Woman’s Health Hospital, Assiut University, Assiut, Egypt. E. A. Khlifah, Professor at the Department of Obstetrics and Gynecology, Consultant at Woman’s Health Hospital, Assiut University, Assiut, Egypt. A. M. Esmail, Professor at the Department of Obstetrics and Gynecology, Consultant at Woman’s Health Hospital, Assiut University, Assiut, Egypt. SH. G. Abdelmonem, Resident at the Department of Obstetrics and Gynecology, El eman Hospital, Ministry of Health, Assiut City, Egypt.
Rights and permissions
About this article
Cite this article
Shaamash, A.H., Khlifah, E.A., Esmail, A.M. et al. Home-Based Extended Low-Dose Oral Misoprostol in Management of First-Trimester Pregnancy Loss in Low-Resource Communities: A Randomized Trial. J Obstet Gynecol India 69, 501–508 (2019). https://doi.org/10.1007/s13224-019-01247-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13224-019-01247-x