scholarly journals Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

2019 ◽  
Author(s):  
Margo Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Routine Care ◽  
Postpartum Visit ◽  
Postpartum Contraception ◽  
Home Setting ◽  
Home Based ◽  
Cluster Randomized ◽  
Long Acting

Abstract Abstract Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion: A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.

scholarly journals Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Margo S. Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Routine Care ◽  
Postpartum Visit ◽  
Postpartum Contraception ◽  
Home Setting ◽  
Home Based ◽  
Cluster Randomized ◽  
Long Acting

Abstract Background Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. Trial registration Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.

scholarly journals Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

2019 ◽  
Author(s):  
Margo Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Trial Registration ◽  
Postpartum Visit ◽  
Postpartum Contraception ◽  
Home Setting ◽  
Home Based ◽  
Cluster Randomized ◽  
Long Acting

Abstract Background Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. Retrospective Trial Registration clinicaltrials.gov Trial Identifying Number NCT04005391 Date of Registration in Primary Registry: July 1, 2019 Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04005391?term=NCT04005391&rank=1 Keywords: postpartum contraception, long-acting reversible contraceptives, implant, nursing, community programming, cluster-randomized trial

scholarly journals Twelve-month Outcomes of a Cluster-randomized Trial of Home-based Postpartum Contraceptive Delivery in Southwest Trifinio, Guatemala

2020 ◽  
Author(s):  
Margo Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Contraceptive Use ◽  
Short Interval ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Routine Care ◽  
Postpartum Visit ◽  
Home Based ◽  
Cluster Randomized ◽  
Long Acting

Abstract Design: We executed a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with three and 12-month contraceptive utilization, satisfaction, and pregnancy rates.Methods: Eight clusters were randomized to receive either the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit in addition to routine care, or routine care alone, which included comprehensive contraceptive counseling throughout antepartum care. Results: 208 women were enrolled in the study, 108 in the intervention clusters and 100 in control clusters. 94 (87.0%) women in the intervention group and 91 (91%) of women in control clusters were evaluated 12 months post-enrollment. Likelihood of using contraception at that time was borderline increased in intervention clusters (RR 1.1 [1.0,1.3], p = 0.05) with an increased likelihood of long-acting contraceptive use (the implant; RR 1.6 [1.3,1.9], p < 0.001). Pregnancy rates were also borderline reduced in the intervention clusters (RR 1.0 [1.0,1.1], p = 0.07). There was no difference in satisfaction of women with contraceptive use between arms with about 95% of women very satisfied or a little satisfied in each arm. Continuation rates at twelve months of contraceptives in the intervention group were 0.0% for condom users, 80.0% for contraceptive pill users, 57% for injectable users, and 83% for implant users. Most women who discontinued their initial method chose a more long-term or permanent method. There was a trend toward a significant association with reduced short interval pregnancy.Conclusion: Our study had a borderline increase in overall use of contraception by 12 months, did have an increased likelihood of long-acting contraceptive use of the implant by 12 months, and resulted in a trend toward reduced short interval pregnancy in the intervention clusters as compared to control clusters. Registration: clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391Protocol: https://doi.org/10.1186/s13063-019-3735-3

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

2020 ◽  
Author(s):  
Margo Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Contraceptive Use ◽  
Pragmatic Trial ◽  
Care Program ◽  
Cluster Randomized Trial ◽  
Routine Care ◽  
Adverse Outcomes ◽  
Antenatal Visit ◽  
Postpartum Visit ◽  
Home Based ◽  
Cluster Randomized

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.Registration: clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391Protocol: https://doi.org/10.1186/s13063-019-3735-3

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

2020 ◽  
Author(s):  
Margo Harrison ◽  
Saskia Bunge-Montes ◽  
Claudia Rivera ◽  
Andrea Jimenez-Zambrano ◽  
Gretchen Heinrichs ◽  
...  
Keyword(s):  
Contraceptive Use ◽  
Pragmatic Trial ◽  
Care Program ◽  
Cluster Randomized Trial ◽  
Routine Care ◽  
Adverse Outcomes ◽  
Antenatal Visit ◽  
Postpartum Visit ◽  
Home Based ◽  
Cluster Randomized

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 Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. 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 (2.0%), p < 0.001, OR 18.8 CI [4.3, 81.4]. 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.

Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Karen L Margolis ◽  
Stephen E Asche ◽  
Anna R Bergdall ◽  
Steven P Dehmer ◽  
Beverly B Green ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Home Blood Pressure ◽  
Uncontrolled Hypertension ◽  
Routine Clinical Care ◽  
Differential Reduction ◽  
Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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