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Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community

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Abstract

Background/Purpose

Misoprostol is beneficial in preventing postpartum haemorrhage (PPH). However, there is no consensus yet as to which route will give the balance of efficacy, safety and patient preference, especially at the recommended dose of 600 mcg. This study compared the efficacy and adverse effects of rectal and sublingual misoprostol for the prevention of PPH.

Methods

In a prospective fashion, consenting eligible parturients were randomised into two groups to receive either 600 mcg of misoprostol rectally or sublingually after vaginal delivery. All study participants were followed up till 24 h postpartum. Primary outcomes were blood loss of 500 ml or greater and at least 10% change in peripartum haematocrit levels.

Results

Seven (6.7%) and 16 (15.7%) of the sublingual and rectal routes, respectively, had PPH. However, the odds of having PPH after rectal misoprostol were at least twice the odds after the sublingual route (p = 0.041). Also, the mean blood loss after the first, fourth and 24th hour postpartum were significantly higher after rectal administration. Although significantly more patients had shivering and pyrexia after sublingual misoprostol, it was acceptable to more participants than the rectal route.

Conclusion

At the recommended dose, sublingually administered misoprostol (‘the sweet of life’) is associated with a lower incidence of PPH than the rectal route. Despite its higher incidence of shivering and pyrexia, it was accepted by more women than rectally administered misoprostol.

ClinicalTrials.gov identifier PACTR201911500348367.

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Data Availability

The data can be obtained from the trials registry, or from the authors after due permission from the institution.

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Acknowledgements

The authors wish to acknowledge the contributions of the staff of the labour ward, the resident doctors and consultants in the Department to the success of the study.

Funding

The study was entirely self-funded.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Ekiti State University, P.M.B. 5363, Ado Ekiti, Nigeria

    Jacob Olumuyiwa Awoleke, Olusola Peter Aduloju & Babatunde Ajayi Olofinbiyi

  2. Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, P.M.B. 5355, Ado Ekiti, Nigeria

    Jacob Olumuyiwa Awoleke, Benedict Tolulope Adeyanju, Olusola Peter Aduloju & Babatunde Ajayi Olofinbiyi

  3. Department of Obstetrics and Gynaecology, Federal Teaching Hospital, Ido Ekiti, Nigeria

    Adebayo Adeniyi

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  1. Jacob Olumuyiwa Awoleke
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  4. Olusola Peter Aduloju
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by BTA and JOA. The first draft of the manuscript was written by JOA, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jacob Olumuyiwa Awoleke.

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Conflict of interest

The authors declare that there are no conflicts of interests.

Ethical Statement

The study was done in accordance with the 1964 Declaration of Helsinki. All recruited patients were adequately counselled and their written informed consent obtained. They were at liberty to decline participation without any negative impact on the quality of care they will receive in the hospital. The institution’s Ethics and Research Committee gave approval for the study, which was designed and reported in line with the CONSORT Statement 2010.

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Dr. Awoleke is an Associate Professor in the Department of Obstetrics and Gynaecology, College of Medicine, Ekiti State University, Ado-Ekiti, Nigeria. Benedict Tolulope Adeyanju: MBChB in the Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, Ado – Ekiti, Nigeria, Adebayo Adeniyi: MBBS, FWACS, FMCOG in the Department of Obstetrics and Gynaecology, Federal Teaching Hospital, Ido – Ekiti, Nigeria, Olusola Peter Aduloju: MBBS, MPH, FWACS in the Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, Ado – Ekiti, Nigeria and Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, Ado – Ekiti, Nigeria, Babatunde Ajayi Olofinbiyi: MBBS, FWACS in the Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, Ado – Ekiti, Nigeria and Department of Obstetrics and Gynaecology, Ekiti State University Teaching Hospital, Ado – Ekiti, Nigeria.

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Awoleke, J.O., Adeyanju, B.T., Adeniyi, A. et al. Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community. J Obstet Gynecol India 70, 462–470 (2020). https://doi.org/10.1007/s13224-020-01338-0

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  • DOI: https://doi.org/10.1007/s13224-020-01338-0

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