Group Antenatal/Postnatal Care in Rwanda
Condition: Pregnancy Complications; Preterm Birth; Preterm Labor; Stillbirth; Low Birth Weight; Neonatal Mortality
MeSH terms: Premature Birth; Obstetric Labor, Premature; Pregnancy Complications; Stillbirth; Birth Weight
Study type: Interventional

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 model's 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 women's 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 ANC/PNC 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 Rwanda's ANC/PNC 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 midwife/nurse 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.
    

Intervention name(s): Group ANC/PNC; Ultrasound+Pregnancy Testing
Intervention type(s): Behavioral; Procedure
Intervention description(s): The primary intervention is group antenatal and postnatal care wherein women receive their care in a group with other women with similar due dates. After an initial individual visit all care is given in groups although the majority of the time is dedicated to facilitated discussion and women can come for additional acute care if needed. Group antenatal care will be three group visits between 20 and 40 weeks gestation and group postnatal care will be one group visit and approximately 6 weeks post delivery.; Half of all study sites will receive early pregnancy testing, conducted by community health workers at community level and ultrasound for gestational age dating and early screening at the health center.
The primary analysis will not assess the effectiveness of this intervention.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment