Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03154177
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2017-04-14
Brief Title:
Group AntenatalPostnatal Care in Rwanda
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Group AntenatalPostnatal Care in Rwanda a Cluster Randomized Control Trial RCT to Measure Its Effectiveness on Increasing Gestational Age Mortality Among Preterm and Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTBi Rwanda
Brief Summary:
The focus of this work is to improve antenatal care ANC and postnatal care PNC at the health center level in five districts in Rwanda Bugesera Burera Nyamasheke Nyarugenge and Rubavu 36 health centers in these districts are included in this cluster randomized control trial RCT of group ANC and PNC care to measure this alternative models effects on gestational age at birth survival of preterm and low birth weight infants at 42 days of life and ANC and PNC coverage To improve antenatal assessment of gestational age nurses will be trained in obstetric ultrasound at 18 health centers These facilities will also incorporate pregnancy testing with urine dipstick to be performed by community health workers in charge of maternal health to facilitate early entry into ANC This trial will test the hypothesis that women who participate in this alternative model of group ANC will experience increased gestational age at birth as compared to women who receive standard focused ANC This study is a collaboration with the University of Rwanda the Rwandan Ministry of Health MOH the Rwanda Biomedical Center and UCSF
The group care model used in this study is Rwanda-specific model developed by a Rwandan technical working group The model includes an individual clinical visit for the first antenatal visit followed by three group visits spaced about 8 weeks apart throughout pregnancy and a postnatal group visit at approximately 6 weeks after birth Women will be grouped into stable groups of approximately 8-12 women with similar due dates A community health worker CHW and a health center nurse will work together as co-facilitators to lead each of the groups Each group visit includes clinical assessment education and treatments as appropriate for the women who attend The model is founded on facilitative leadership of the groups in which the co-facilitators allow womens experiences and interests to drive the content and women are encouraged to help one another cope with obstacles to optimal health Facilitators will be supported by master trainers who will visit health centers to observe group sessions and offer supportive feedback
Data collected in this trial will include measures of the satisfaction of both women and providers with the group care content of care differences between standard and group care and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth weight infant survival
The group care model used in this study is Rwanda-specific model developed by a Rwandan technical working group The model includes an individual clinical visit for the first antenatal visit followed by three group visits spaced about 8 weeks apart throughout pregnancy and a postnatal group visit at approximately 6 weeks after birth Women will be grouped into stable groups of approximately 8-12 women with similar due dates A community health worker CHW and a health center nurse will work together as co-facilitators to lead each of the groups Each group visit includes clinical assessment education and treatments as appropriate for the women who attend The model is founded on facilitative leadership of the groups in which the co-facilitators allow womens experiences and interests to drive the content and women are encouraged to help one another cope with obstacles to optimal health Facilitators will be supported by master trainers who will visit health centers to observe group sessions and offer supportive feedback
Data collected in this trial will include measures of the satisfaction of both women and providers with the group care content of care differences between standard and group care and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth weight infant survival
Detailed Description:
This study aims to determine the effect of a group care model which incorporates both group care antenatal ANC and postnatal care PNC on the following
1 Gestational age GA at birth
2 Adherence to the recommended four ANC and one facility-based PNC visits and
3 Mortality at 42 days among preterm and low birth weight infants
In this cluster RCT at the health center level facilities will be pair-matched based on factors affecting GA at delivery such as monthly ANC enrollment quality of ANC and PNC delivery potential lost-to-follow-up LTFU rate and additional criteria pertaining to facility capacity Within each pair a facility will be randomly chosen to implement the intervention group ANC and PNC while the control facility will continue to provide standard ANC and PNC Pairs will then be further matched with other pairs into quadruples to the extent possible within which one pair will be assigned to additionally implement ultrasound at the health center level and early pregnancy testing at the community level Overall each facility will have one of the following assignments
Arm 1 Standard ANC and PNC care only
Arm 2 Standard ANC and PNC care with the addition of early pregnancy testing and ultrasound
Arm 3 Group ANC and PNC only
Arm 4 Group ANC and PNC care with the addition of early pregnancy testing and ultrasound
This design will allow a primary analysis on the difference between group care and standard care and will also make it possible to assess the effect of early pregnancy testing in the community and obstetric ultrasound at the health center on early entry into ANC and number of visits attended
The Rwanda group ANCPNC model was developed by a Technical Working Group of representatives from maternal-child health stakeholders in Rwanda Key characteristics
1 Women sit in a circle in a group space where confidentiality and mutual respect are prioritized Key messages consistent with Rwandas ANCPNC packages are delivered through facilitated discussion women speak more than the facilitators
2 Women and newborns receive the routine assessments screening and treatments described in the Rwanda guidelines as well as treatments indicated for special conditions Health assessments are conducted at the start of the visit and women participate as much as possible in their own self-assessments Individual consultations with facilitators are conducted in a semi-private area
3 Two co-facilitators lead each group visit one midwifenurse and one CHW Co-facilitators debrief after every group visit in a continuous learning and quality improvement process The group care co-facilitators are trained and supported by 6 Rwandan Master Trainers
4 Women can return to the health facility at any time for evaluation of danger signs or other concerns Referrals to the district hospital are done per current national guidelines
Both control and intervention sites as well as district hospitals that may receive referrals from our study sites will receive the initial intervention of data strengthening and training around data use activities so as to improve the quality of data being collected and strengthen outcome measurement within all facilities involved in the study
Additionally in order to evaluate other secondary outcomes data will also be collected through 1 questionnaires administered to a random sample of ANC and PNC participants and all providers at baseline and different time points throughout the study 2 observations and debriefs of group care sessions 3 qualitative research around acceptability of the group model from participants and providers 4 cost-effectiveness analysis of the group care model
1 Gestational age GA at birth
2 Adherence to the recommended four ANC and one facility-based PNC visits and
3 Mortality at 42 days among preterm and low birth weight infants
In this cluster RCT at the health center level facilities will be pair-matched based on factors affecting GA at delivery such as monthly ANC enrollment quality of ANC and PNC delivery potential lost-to-follow-up LTFU rate and additional criteria pertaining to facility capacity Within each pair a facility will be randomly chosen to implement the intervention group ANC and PNC while the control facility will continue to provide standard ANC and PNC Pairs will then be further matched with other pairs into quadruples to the extent possible within which one pair will be assigned to additionally implement ultrasound at the health center level and early pregnancy testing at the community level Overall each facility will have one of the following assignments
Arm 1 Standard ANC and PNC care only
Arm 2 Standard ANC and PNC care with the addition of early pregnancy testing and ultrasound
Arm 3 Group ANC and PNC only
Arm 4 Group ANC and PNC care with the addition of early pregnancy testing and ultrasound
This design will allow a primary analysis on the difference between group care and standard care and will also make it possible to assess the effect of early pregnancy testing in the community and obstetric ultrasound at the health center on early entry into ANC and number of visits attended
The Rwanda group ANCPNC model was developed by a Technical Working Group of representatives from maternal-child health stakeholders in Rwanda Key characteristics
1 Women sit in a circle in a group space where confidentiality and mutual respect are prioritized Key messages consistent with Rwandas ANCPNC packages are delivered through facilitated discussion women speak more than the facilitators
2 Women and newborns receive the routine assessments screening and treatments described in the Rwanda guidelines as well as treatments indicated for special conditions Health assessments are conducted at the start of the visit and women participate as much as possible in their own self-assessments Individual consultations with facilitators are conducted in a semi-private area
3 Two co-facilitators lead each group visit one midwifenurse and one CHW Co-facilitators debrief after every group visit in a continuous learning and quality improvement process The group care co-facilitators are trained and supported by 6 Rwandan Master Trainers
4 Women can return to the health facility at any time for evaluation of danger signs or other concerns Referrals to the district hospital are done per current national guidelines
Both control and intervention sites as well as district hospitals that may receive referrals from our study sites will receive the initial intervention of data strengthening and training around data use activities so as to improve the quality of data being collected and strengthen outcome measurement within all facilities involved in the study
Additionally in order to evaluate other secondary outcomes data will also be collected through 1 questionnaires administered to a random sample of ANC and PNC participants and all providers at baseline and different time points throughout the study 2 observations and debriefs of group care sessions 3 qualitative research around acceptability of the group model from participants and providers 4 cost-effectiveness analysis of the group care model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None