Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania

Objective To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. Methods A multi‐site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women age...

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Veröffentlicht in:International journal of gynecology and obstetrics 2017-12, Vol.139 (3), p.290-296
Hauptverfasser: Patil, Crystal L., Klima, Carrie S., Steffen, Alana D., Leshabari, Sebalda C., Pauls, Heather, Norr, Kathleen F.
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container_end_page 296
container_issue 3
container_start_page 290
container_title International journal of gynecology and obstetrics
container_volume 139
creator Patil, Crystal L.
Klima, Carrie S.
Steffen, Alana D.
Leshabari, Sebalda C.
Pauls, Heather
Norr, Kathleen F.
description Objective To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. Methods A multi‐site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20–24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6–8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6‐week postnatal visit. Results The pilot showed that an RCT with individual randomization can be conducted in these two low‐resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P
doi_str_mv 10.1002/ijgo.12324
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Methods A multi‐site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20–24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6–8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6‐week postnatal visit. Results The pilot showed that an RCT with individual randomization can be conducted in these two low‐resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P&lt;0.001). Conclusion Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334 Pilot results from Malawi and Tanzania show that group prenatal care is associated with increased healthcare utilization and that a randomized controlled trial is feasible.</description><identifier>ISSN: 0020-7292</identifier><identifier>EISSN: 1879-3479</identifier><identifier>DOI: 10.1002/ijgo.12324</identifier><identifier>PMID: 28905377</identifier><language>eng</language><publisher>United States</publisher><subject>Adolescent ; Adult ; CenteringPregnancy ; Feasibility Studies ; Female ; Group healthcare models ; Group prenatal care ; Health Plan Implementation ; Humans ; Malawi ; Patient Acceptance of Health Care - statistics &amp; numerical data ; Pilot Projects ; Postnatal Care - methods ; Pregnancy ; Prenatal care ; Prenatal Care - methods ; Psychotherapy, Group - methods ; Quality of care ; Randomized Controlled Trials as Topic - methods ; Respectful care ; Sub‐Saharan Africa ; Tanzania ; Young Adult</subject><ispartof>International journal of gynecology and obstetrics, 2017-12, Vol.139 (3), p.290-296</ispartof><rights>2017 International Federation of Gynecology and Obstetrics</rights><rights>2017 International Federation of Gynecology and Obstetrics.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4864-4a20e11c7835f5e64a1cdee58b8c8a094c010a54c9cd17e210e9da9289c9495f3</citedby><cites>FETCH-LOGICAL-c4864-4a20e11c7835f5e64a1cdee58b8c8a094c010a54c9cd17e210e9da9289c9495f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fijgo.12324$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fijgo.12324$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28905377$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Patil, Crystal L.</creatorcontrib><creatorcontrib>Klima, Carrie S.</creatorcontrib><creatorcontrib>Steffen, Alana D.</creatorcontrib><creatorcontrib>Leshabari, Sebalda C.</creatorcontrib><creatorcontrib>Pauls, Heather</creatorcontrib><creatorcontrib>Norr, Kathleen F.</creatorcontrib><title>Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania</title><title>International journal of gynecology and obstetrics</title><addtitle>Int J Gynaecol Obstet</addtitle><description>Objective To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. Methods A multi‐site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20–24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6–8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6‐week postnatal visit. Results The pilot showed that an RCT with individual randomization can be conducted in these two low‐resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P&lt;0.001). Conclusion Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334 Pilot results from Malawi and Tanzania show that group prenatal care is associated with increased healthcare utilization and that a randomized controlled trial is feasible.</description><subject>Adolescent</subject><subject>Adult</subject><subject>CenteringPregnancy</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Group healthcare models</subject><subject>Group prenatal care</subject><subject>Health Plan Implementation</subject><subject>Humans</subject><subject>Malawi</subject><subject>Patient Acceptance of Health Care - statistics &amp; numerical data</subject><subject>Pilot Projects</subject><subject>Postnatal Care - methods</subject><subject>Pregnancy</subject><subject>Prenatal care</subject><subject>Prenatal Care - methods</subject><subject>Psychotherapy, Group - methods</subject><subject>Quality of care</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Respectful care</subject><subject>Sub‐Saharan Africa</subject><subject>Tanzania</subject><subject>Young Adult</subject><issn>0020-7292</issn><issn>1879-3479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFPFTEQxxsjkSd68QOYHo3JYrvbvm0vJoYIPgPhAudm6M4-Srrt2u5KHle_OIVFohdOzXR--c1M_oR84OyQM1Z_cTfbeMjrphavyIqrVleNaPVrsipNVrW1rvfJ25xvGGO85fwN2a-VZrJp2xX5sxlGjwOGCSYXA7XX4D2GLWYKoaNxnmwcShF7CjSVrzi4O-yojWFKsaAdHZ2PE83T3O0WbJviPNIxYYAJPLWQkA6xQ09doGfg4dY9yi8g3EFw8I7s9eAzvn96D8jl8feLox_V6fnJ5ujbaWWFWotKQM2Qc9uqRvYS1wK47RClulJWAdPCMs5ACqttx1usOUPdgS63Wi207JsD8nXxjvPVgJ0tRyfwZkxugLQzEZz5vxPctdnG30au20YKVQSfngQp_poxT2Zw2aL3EDDO2XDdKCW5lKKgnxfUpphzwv55DGfmITXzkJp5TK3AH_9d7Bn9G1MB-ALcOo-7F1Rm8_PkfJHeA2ukpdE</recordid><startdate>201712</startdate><enddate>201712</enddate><creator>Patil, Crystal L.</creator><creator>Klima, Carrie S.</creator><creator>Steffen, Alana D.</creator><creator>Leshabari, Sebalda C.</creator><creator>Pauls, Heather</creator><creator>Norr, Kathleen F.</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201712</creationdate><title>Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania</title><author>Patil, Crystal L. ; Klima, Carrie S. ; Steffen, Alana D. ; Leshabari, Sebalda C. ; Pauls, Heather ; Norr, Kathleen F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4864-4a20e11c7835f5e64a1cdee58b8c8a094c010a54c9cd17e210e9da9289c9495f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>CenteringPregnancy</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Group healthcare models</topic><topic>Group prenatal care</topic><topic>Health Plan Implementation</topic><topic>Humans</topic><topic>Malawi</topic><topic>Patient Acceptance of Health Care - statistics &amp; numerical data</topic><topic>Pilot Projects</topic><topic>Postnatal Care - methods</topic><topic>Pregnancy</topic><topic>Prenatal care</topic><topic>Prenatal Care - methods</topic><topic>Psychotherapy, Group - methods</topic><topic>Quality of care</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Respectful care</topic><topic>Sub‐Saharan Africa</topic><topic>Tanzania</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Patil, Crystal L.</creatorcontrib><creatorcontrib>Klima, Carrie S.</creatorcontrib><creatorcontrib>Steffen, Alana D.</creatorcontrib><creatorcontrib>Leshabari, Sebalda C.</creatorcontrib><creatorcontrib>Pauls, Heather</creatorcontrib><creatorcontrib>Norr, Kathleen F.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International journal of gynecology and obstetrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Patil, Crystal L.</au><au>Klima, Carrie S.</au><au>Steffen, Alana D.</au><au>Leshabari, Sebalda C.</au><au>Pauls, Heather</au><au>Norr, Kathleen F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania</atitle><jtitle>International journal of gynecology and obstetrics</jtitle><addtitle>Int J Gynaecol Obstet</addtitle><date>2017-12</date><risdate>2017</risdate><volume>139</volume><issue>3</issue><spage>290</spage><epage>296</epage><pages>290-296</pages><issn>0020-7292</issn><eissn>1879-3479</eissn><abstract>Objective To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. Methods A multi‐site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20–24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6–8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6‐week postnatal visit. Results The pilot showed that an RCT with individual randomization can be conducted in these two low‐resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P&lt;0.001). Conclusion Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334 Pilot results from Malawi and Tanzania show that group prenatal care is associated with increased healthcare utilization and that a randomized controlled trial is feasible.</abstract><cop>United States</cop><pmid>28905377</pmid><doi>10.1002/ijgo.12324</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Adolescent
Adult
CenteringPregnancy
Feasibility Studies
Female
Group healthcare models
Group prenatal care
Health Plan Implementation
Humans
Malawi
Patient Acceptance of Health Care - statistics & numerical data
Pilot Projects
Postnatal Care - methods
Pregnancy
Prenatal care
Prenatal Care - methods
Psychotherapy, Group - methods
Quality of care
Randomized Controlled Trials as Topic - methods
Respectful care
Sub‐Saharan Africa
Tanzania
Young Adult
title Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania
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