Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala

Margo S Harrison, Saskia Bunge-Montes, Claudia Rivera, Andrea Jimenez-Zambrano, Gretchen Heinrichs, Antonio Bolanos, Edwin Asturias, Stephen Berman, Jeanelle Sheeder, Margo S Harrison, Saskia Bunge-Montes, Claudia Rivera, Andrea Jimenez-Zambrano, Gretchen Heinrichs, Antonio Bolanos, Edwin Asturias, Stephen Berman, Jeanelle Sheeder

Abstract

Design: This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment.

Methods: In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention.

Results: Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4].

Conclusion: Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported.

Trial registration: clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

Keywords: Guatemala; Implant; Postpartum contraception.

Conflict of interest statement

The authors have no relationships to disclose that may be deemed to influence the objectivity of this paper and its review. The authors report no commercial associations, either directly or through immediate family, in areas such as expert testimony, consulting, honoraria, stock holdings, equity interest, ownership, patent-licensing situations or employment that might pose a conflict of interest to this analysis. Additionally, the authors have no conflicts such as personal relationships or academic competition to disclose. The findings presented in this paper represent the views of the named authors only, and not the views of their institutions or organizations. A consent for publication section was not necessary. No individual-level data is presented in this manuscript, only de-identified aggregated data of women who consented to participate in the study and publication of the analysis.

Figures

Fig. 1
Fig. 1
Map of the Southwest Trifinio Region and Communities
Fig. 2
Fig. 2
CONSORT DIAGRAM
Fig. 3
Fig. 3
INTERVENTION CLUSTERS, Enrollment and Three-Month Contraceptive Use Among Women. NFP: Natural Family Planning, LAM: Lactational Amenorrhea, IUD: Intrauterine Device
Fig. 4
Fig. 4
CONTROL CLUSTERS, Contraceptive Use by Three Months

References

    1. Harrison MS, Goldenberg RL. Immediate postpartum use of long-acting reversible contraceptives in low- and middle-income countries. Matern Health Neonatol Perinatol. 2017;3:24.
    1. Darroch JE, Sully E, Biddlecom A. Adding it up: investing in contraception and maternal and newborn health, 2017—supplementary tables. The Guttmacher Institute: New York; 2017.
    1. Pasha O, Goudar SS, Patel A, et al. Postpartum contraceptive use and unmet need for family planning in five low-income countries. Reprod Health. 2015;12(Suppl 2):S11.
    1. Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203(2):115.e111–115.e117.
    1. Schultz C, Larrea N, Celada M, Heinrichs G. A qualitative assessment of community attitudes and barriers to family planning use in the Trifinio region of Southwest Guatemala. Matern Child Health J. 2018;22(4):461–466.
    1. Harrison MS, Bunge-Montes S, Rivera C, et al. Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol. Trials. 2019;20(1):639.
    1. Asturias EJ, Heinrichs G, Domek G, et al. The Center for Human Development in Guatemala. Adv Pediatr Infect Dis. 2016;63(1):357–387.
    1. Carter MW. Because he loves me': husbands' involvement in maternal health in Guatemala. Cult Health Sex. 2002;4(3):259–279.
    1. Organization WH . WHO technical consultation on postpartum and postnatal care. Geneva: World Health Organization; 2010.
    1. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1–103.
    1. Ponce De Leon RG, Ewerling F, Serruya SJ, et al. Contraceptive use in Latin America and the Caribbean with a focus on long-acting reversible contraceptives: prevalence and inequalities in 23 countries. Lancet Glob Health. 2019;7(2):e227–e235.
    1. Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117(5):1105–1113.
    1. Moore Z, Pfitzer A, Gubin R, Charurat E, Elliott L, Croft T. Missed opportunities for family planning: an analysis of pregnancy risk and contraceptive method use among postpartum women in 21 low- and middle-income countries. Contraception. 2015;92(1):31–39.
    1. Khamishon R, Chen J, Ranatunge N, et al. Use and perception of contraception among genders in Santo Domingo, Dominican Republic. Ann Glob Health. 2019;85(1):90.
    1. Harrison MS, Zucker R, Scarbro S, Sevick C, Sheeder J, Davidson AJ. Postpartum Contraceptive Use Among Denver-Based Adolescents and Young Adults: Association with Subsequent Repeat Delivery. Journal of Pediatric and Adolescent Gynecology. 2020 Apr 3. 10.1016/j.jpag.2020.03.012.
    1. Brunson MR, Klein DA, Olsen CH, Weir LF, Roberts TA. Postpartum contraception: initiation and effectiveness in a large universal healthcare system. Am J Obstet Gynecol. 2017;217(1):55. e51–55. e59.

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