Labor PainBBBNCT02550730
Best Beginnings for Babies Birth Sister Program Evaluation
A study testing Birth Sisters Best Beginnings for Babies and Usual maternity care in people with Labor Pain, run by Boston Medical Center at 1 site in United States.
Trial summary
Peer support during labor, birth and the perinatal period (also known as "doula" support) has been shown in some studies to reduce cesarean rates, postpartum depression and increase breastfeeding rates. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Birth Sisters Best Beginnings for Babies and Usual maternity care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being a pregnant Woman 16 to 24 gestational age
- First Time Mother
- Singleton
- Public insurance
- No known fetal anomaly
Who cannot join
- < 18 years of age
- high risk pregnancy defined by care in the high-risk prenatal clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center
Boston, Massachusetts, 021182335
About this study
Official title: Birth Sisters Best Beginnings Evaluation
Peer support during labor, birth and the perinatal period (also known as "doula" support) has been shown in some studies to reduce cesarean rates, postpartum depression and increase breastfeeding rates. The purpose of this program evaluation is to prospectively assess the clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the few established, hospital-based programs in the United States. To enhance the capability of the Birth Sisters Program to impact social determinants of perinatal health in a low-income population, the program evaluation will include the addition of Medical Legal Partnership for Children's (MLP) training and referral services. This program will be described as the Birth Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB compared with no Birth Sister support for women receiving maternity care at Boston Medical Center. Eligible women will be randomly assigned either BBB services or usual care. All women will be consented and interviewed in the mid-second trimester of pregnancy and interviewed again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy, continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the home or at Boston Medical Center. The usual care group will receive no birth sister support but does have access to standard interdisciplinary maternity care services. The primary outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including depression, social functioning and self-efficacy.
Read the detailed description
Racial and income disparities in maternal and perinatal outcomes in the United States are large and persistent. Maternal and infant morbidity and mortality alike are 2-3 times higher in the black population than in the white population. Poor women in general are more likely to have babies born prematurely or with low birth weight compared with women from a higher socio economic strata. Infants born either too early or too small are at risk for a lifetime of disabilities, perpetuating the cycle of poverty and poor health. Low-income and minority populations are also less likely to breastfeed, putting children and mothers at higher risk for a variety of health problems, including obesity, diabetes, and some cancers.
In addition to income and racial disparities, the nation as a whole struggles with inferior maternity care outcomes when compared with other developed countries. This is true despite considerably higher rates of maternity care expenditures. The unnecessarily high rate of cesarean birth is one factor that contributes to both high cost and poor outcomes. The Society of Maternal and Fetal Medicine and the American Congress of Obstetricians and Gynecologists have both called for innovations and strategies to reduce the high rate of cesarean birth.
Community "doulas", or peer support during pregnancy, labor and birth, is one intervention that may both improve outcomes for low-income populations and lower the cost of maternity care. A culturally competent peer who provides caring support during a crucial life transition may lower stress and improve engagement in healthcare, therefore improving health status during pregnancy and lowering the need for costly medical care. Low income and minority women are more likely to desire a doula during labor and less likely to have access to their services.
The Birth Sisters Program One of the few hospital-based community doula programs in the country, Boston Medical Center's Birth Sisters Program has provided multicultural doula support to childbearing women since 1999. The approximately 20 per diem Birth Sisters together speak over 10 languages. Birth Sisters are recruited from the communities served by the BMC maternity service and provide peer support throughout the perinatal period. Prenatal home visits focus on creating a relationship, identifying psychosocial needs and providing childbirth and breastfeeding education. The Birth Sister also assesses whether the woman is lacking in essential resources such as housing, food and baby care items. She then refers her client to social service agencies and helps her navigate those services as needed. During labor, the Birth Sister offers physical and emotional comfort measures, advocacy for the mother, and help with the first breastfeeding. Postpartum home visits provide assistance in the transition to motherhood, help around the house so that the mother can rest, education on breastfeeding, parenting and infant care, and connections to needed medical and social services.
The Birth Sisters Program does not have resources to serve all women who would like a Birth Sister. investigators are currently able to meet approximately 20 percent of the demand. Prenatal providers have traditionally been the primary referral source for the program, with some providers referring often and others rarely referring. This has created inequities in whether women have a chance to receive a Birth Sister. investigators are now changing the referral process to systematically screen all potentially eligible women and allow eligible women to self-refer to the Birth Sister pool. A limited number of Birth Sister assignments are made from this pool each month. Women are informed about the Birth Sister pool through flyers placed in the obstetrical ultrasound unit and, if they would like to be in the pool, they fill out a form with their contact information and place it in the "Birth Sister pool" box. Due to the budget limitations, investigators restrict referrals to women who benefit most, including first time mothers with public insurance.
Because investigators only have resources to serve a small portion of women who want a Birth Sister, investigators have designed an evaluation to provide rigorous evidence about the health and economic outcomes of our program. Prospective, high-quality data is needed to inform policy questions about the benefits of billable community doulas for Medicaid recipients. This is our justification for randomization in a study testing a standard care program.
Purpose The primary objective of the proposed project is to determine the effectiveness of the Birth Sisters Program, in reducing cesarean birth rates and cost of care in a safety net population. The associated objectives are, by the end of the project, to demonstrate significant reductions in: depressive symptoms, low birth weight and preterm birth; and significant increases in breastfeeding rates in women accessing enhanced Birth Sisters as compared to women who are not supported by Birth Sisters. Effective interventions must be sustainable. Cost of care analyses will evaluate whether the incremental costs of the Birth Sisters Program services are justified by the savings brought about by lower rates of labor complications, cesarean sections, emergency room visits and NICU days.
Of note, to improve the ability of the Birth Sisters to address social determinants of health, this evaluation will add training and consultations for Birth Sisters and their clients by Medical Legal Partnership (MLP). MLP is a team of legal experts who integrate legal assistance into the medical setting as a vital component of patient care to ensure that low-income patients are able to meet legal needs that impact on health. They will provide trainings for Birth Sisters on key legal issues, such as housing and benefits. They will also be available for consultation when the mother requires additional resources and information.
Investigators hypothesize that women receiving the BBB intervention will:
- exhibit lower rates of cesarean sections, low birth weight and preterm birth, and neonatal intensive care unit days; and
- exhibit the highest rates of breastfeeding initiation, exclusivity, and continuation;
- experience reductions in depressive symptoms;
- incur lower health care costs than incremental program costs, providing evidence for long-term sustainability.
- Conditions
- Labor Pain
- Being tested
- Birth Sisters Best Beginnings for Babies, Usual maternity care
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth Sisters Best Beginnings for BabiesBehavioural
Birth Sisters Best Beginnings for Babies support during Pregnancy, Labor and Delivery and six weeks postpartum. Participants assigned to the Birth Sister group receive community doula services with consultation from the Medical Legal Partnership when indicated beginning at 24 weeks. Participants receive up to 8 two-hour prenatal home visits; continuous support through labor and birth, and up to 4 two-hour postpartum home visits through 6-8 weeks postpartum.
Usual maternity careOther
Usual prenatal, intrapartum and postpartum maternity care
| Study group | Role | What they receive |
|---|---|---|
| Birth Sisters | Experimental | Half of the women who agree to participate in the evaluation will be randomized to the Birth Sisters Best beginnings for Babies Program, which includes community doula support and consultation with Medical Legal Partnership when indicated. Receives: Behavioral: Birth Sisters Best Beginnings for Babies |
| Routine care | Active comparator | Half of the women who agree to participate in the evaluation will be randomized to the usual maternity care group Receives: Other: Usual maternity care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of cesarean sections
total cesareans/total births as assessed by medical record abstraction
Measured: at delivery
Secondary outcomes (1)
Rates of preterm birth
total preterm births/total births as assessed by medical record abstraction
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Mottl-Santiago, Boston Medical Center
- Investigators
- Julie Mottl-Santiago, MPH, CNM, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550730
- Sponsor's protocol ID
- H-33788
- Acronym
- BBB
- Status last verified
- Jul 2018
- First submitted
- 23 Jun 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mottl-Santiago J, Dukhovny D, Cabral H, Rodrigues D, Spencer L, Valle EA, Feinberg E. Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. Health Equity. 2023 Sep 7;7(1):466-476. doi: 10.1089/heq.2022.0200. eCollection 2023.
PubMed 37731785
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Sisters Best Beginnings Evaluation
- ClinicalTrials.gov ID
- NCT02550730
- Acronym / sponsor ID
- BBB / H-33788
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peer support during labor, birth and the perinatal period (also known as "doula" support) has been shown in some studies to reduce cesarean rates, postpartum depression and increase breastfeeding rates. The purpose of this program evaluation is to prospectively assess the clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the few established, hospital-based programs in the United States. To enhance the capability of the Birth Sisters Program to impact social determinants of perinatal health in a low-income population, the program evaluation will include the addition of Medical Legal Partnership for Children's (MLP) training and referral services. This program will be described as the Birth Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB compared with no Birth Sister support for women receiving maternity care at Boston Medical Center. Eligible women will be randomly assigned either BBB services or usual care. All women will be consented and interviewed in the mid-second trimester of pregnancy and interviewed again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy, continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the home or at Boston Medical Center. The usual care group will receive no birth sister support but does have access to standard interdisciplinary maternity care services. The primary outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including depression, social functioning and self-efficacy.
Detailed description
Racial and income disparities in maternal and perinatal outcomes in the United States are large and persistent. Maternal and infant morbidity and mortality alike are 2-3 times higher in the black population than in the white population. Poor women in general are more likely to have babies born prematurely or with low birth weight compared with women from a higher socio economic strata. Infants born either too early or too small are at risk for a lifetime of disabilities, perpetuating the cycle of poverty and poor health. Low-income and minority populations are also less likely to breastfeed, putting children and mothers at higher risk for a variety of health problems, including obesity, diabetes, and some cancers.
In addition to income and racial disparities, the nation as a whole struggles with inferior maternity care outcomes when compared with other developed countries. This is true despite considerably higher rates of maternity care expenditures. The unnecessarily high rate of cesarean birth is one factor that contributes to both high cost and poor outcomes. The Society of Maternal and Fetal Medicine and the American Congress of Obstetricians and Gynecologists have both called for innovations and strategies to reduce the high rate of cesarean birth.
Community "doulas", or peer support during pregnancy, labor and birth, is one intervention that may both improve outcomes for low-income populations and lower the cost of maternity care. A culturally competent peer who provides caring support during a crucial life transition may lower stress and improve engagement in healthcare, therefore improving health status during pregnancy and lowering the need for costly medical care. Low income and minority women are more likely to desire a doula during labor and less likely to have access to their services.
The Birth Sisters Program One of the few hospital-based community doula programs in the country, Boston Medical Center's Birth Sisters Program has provided multicultural doula support to childbearing women since 1999. The approximately 20 per diem Birth Sisters together speak over 10 languages. Birth Sisters are recruited from the communities served by the BMC maternity service and provide peer support throughout the perinatal period. Prenatal home visits focus on creating a relationship, identifying psychosocial needs and providing childbirth and breastfeeding education. The Birth Sister also assesses whether the woman is lacking in essential resources such as housing, food and baby care items. She then refers her client to social service agencies and helps her navigate those services as needed. During labor, the Birth Sister offers physical and emotional comfort measures, advocacy for the mother, and help with the first breastfeeding. Postpartum home visits provide assistance in the transition to motherhood, help around the house so that the mother can rest, education on breastfeeding, parenting and infant care, and connections to needed medical and social services.
The Birth Sisters Program does not have resources to serve all women who would like a Birth Sister. investigators are currently able to meet approximately 20 percent of the demand. Prenatal providers have traditionally been the primary referral source for the program, with some providers referring often and others rarely referring. This has created inequities in whether women have a chance to receive a Birth Sister. investigators are now changing the referral process to systematically screen all potentially eligible women and allow eligible women to self-refer to the Birth Sister pool. A limited number of Birth Sister assignments are made from this pool each month. Women are informed about the Birth Sister pool through flyers placed in the obstetrical ultrasound unit and, if they would like to be in the pool, they fill out a form with their contact information and place it in the "Birth Sister pool" box. Due to the budget limitations, investigators restrict referrals to women who benefit most, including first time mothers with public insurance.
Because investigators only have resources to serve a small portion of women who want a Birth Sister, investigators have designed an evaluation to provide rigorous evidence about the health and economic outcomes of our program. Prospective, high-quality data is needed to inform policy questions about the benefits of billable community doulas for Medicaid recipients. This is our justification for randomization in a study testing a standard care program.
Purpose The primary objective of the proposed project is to determine the effectiveness of the Birth Sisters Program, in reducing cesarean birth rates and cost of care in a safety net population. The associated objectives are, by the end of the project, to demonstrate significant reductions in: depressive symptoms, low birth weight and preterm birth; and significant increases in breastfeeding rates in women accessing enhanced Birth Sisters as compared to women who are not supported by Birth Sisters. Effective interventions must be sustainable. Cost of care analyses will evaluate whether the incremental costs of the Birth Sisters Program services are justified by the savings brought about by lower rates of labor complications, cesarean sections, emergency room visits and NICU days.
Of note, to improve the ability of the Birth Sisters to address social determinants of health, this evaluation will add training and consultations for Birth Sisters and their clients by Medical Legal Partnership (MLP). MLP is a team of legal experts who integrate legal assistance into the medical setting as a vital component of patient care to ensure that low-income patients are able to meet legal needs that impact on health. They will provide trainings for Birth Sisters on key legal issues, such as housing and benefits. They will also be available for consultation when the mother requires additional resources and information.
Investigators hypothesize that women receiving the BBB intervention will:
- exhibit lower rates of cesarean sections, low birth weight and preterm birth, and neonatal intensive care unit days; and
- exhibit the highest rates of breastfeeding initiation, exclusivity, and continuation;
- experience reductions in depressive symptoms;
- incur lower health care costs than incremental program costs, providing evidence for long-term sustainability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth Sisters | Experimental | Behavioral: Birth Sisters Best Beginnings for BabiesHalf of the women who agree to participate in the evaluation will be randomized to the Birth Sisters Best beginnings for Babies Program, which includes community doula support and consultation with Medical Legal Partnership when indicated. |
| Routine care | Active comparator | Other: Usual maternity careHalf of the women who agree to participate in the evaluation will be randomized to the usual maternity care group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being a pregnant Woman 16 to 24 gestational age
- First Time Mother
- Singleton
- Public insurance
- No known fetal anomaly
Key exclusion criteria (2 listed)
- < 18 years of age
- high risk pregnancy defined by care in the high-risk prenatal clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth Sisters Best Beginnings for BabiesBirth Sisters Best Beginnings for Babies support during Pregnancy, Labor and Delivery and six weeks postpartum. Participants assigned to the Birth Sister group receive community doula services with consultation from the Medical Legal Partnership when indicated beginning at 24 weeks. Participants receive up to 8 two-hour prenatal home visits; continuous support through labor and birth, and up to 4 two-hour postpartum home visits through 6-8 weeks postpartum. | Behavioural | Birth Sisters |
| Usual maternity careUsual prenatal, intrapartum and postpartum maternity care | Other | Routine care |
Primary outcome
Rates of cesarean sections
Time frame: at delivery
total cesareans/total births as assessed by medical record abstraction
1 secondary outcome
Rates of preterm birth
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 37731785Mottl-Santiago J, Dukhovny D, Cabral H, Rodrigues D, Spencer L, Valle EA, Feinberg E. Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. Health Equity. 2023 Sep 7;7(1):466-476. doi: 10.1089/heq.2022.0200. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Mottl-Santiago, MPH, CNM principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth Sisters Best Beginnings for Babies and Usual maternity care in people with Labor Pain, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of cesarean sections (time frame: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.