PregnancyNCT00127361
Study of Having a Female Friend as Labor Support
A study testing doula training in people with Pregnancy and Delivery, Obstetric, run by Saint Peters University Hospital at 1 site in United States.
Trial summary
The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group). Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Delivery, Obstetric
- What is being tested?
- doula training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Feb 2003
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nulliparous (never given birth before)
- Singleton pregnancy
- Vertex presentation
- Low risk pregnancy
- Has a female friend willing to be a doula
Who cannot join
- Placenta previa
- Abruptio placenta
- Multiple pregnancy
- Breech presentation
- Planned operative delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Peters University Hospital
New Brunswick, New Jersey, 07109
About this study
Official title: Evaluation of Continuous Support in Labor
The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).
The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.
Read the detailed description
The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).
- Conditions
- Pregnancy, Delivery, Obstetric
- Being tested
- doula training
- Keywords
- doula, caregivers, labor support, being with woman, continuous labor support, maternal outcomes, Parturition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doula trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of labor
type of delivery
type and timing of analgesia/anesthesia
Secondary outcomes (2)
Birthweight
neonatal Apgar score at 1 and 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJan 1998
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Saint Peters University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Della A Campbell, PhDc, Principal investigator, Saint Peters University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127361
- Sponsor's protocol ID
- DAC-1998
- Status last verified
- Apr 2005
- First submitted
- 4 Aug 2005
- Last updated
- 23 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Continuous Support in Labor
- ClinicalTrials.gov ID
- NCT00127361
- Acronym / sponsor ID
- DAC-1998
- Conditions
- Pregnancy, Delivery, Obstetric
- Keywords
- doula, caregivers, labor support, being with woman, continuous labor support, maternal outcomes, Parturition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Saint Peters University HospitalUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- Feb 2003
- First posted
- 5 Aug 2005 (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.
The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).
The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.
Detailed description
The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Nulliparous (never given birth before)
- Singleton pregnancy
- Vertex presentation
- Low risk pregnancy
- Has a female friend willing to be a doula
Key exclusion criteria (5 listed)
- Placenta previa
- Abruptio placenta
- Multiple pregnancy
- Breech presentation
- Planned operative delivery
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 |
|---|---|---|
| doula training | Behavioural | – |
Primary outcome
Length of labor
type of delivery
type and timing of analgesia/anesthesia
2 secondary outcomes
Birthweight
neonatal Apgar score at 1 and 5 minutes after birth
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 23 Aug 2005.
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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.
Della A Campbell, PhDc principal investigator
Saint Peters University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doula training in people with Pregnancy and Delivery, Obstetric, run by Saint Peters University Hospital 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 5 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 23 Aug 2005. 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?
Length of labor. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2005.