Labor LongNCT04771325
Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda
A study testing Support from a trained companion in people with Labor Long, run by Makerere University at 1 site in Uganda.
Trial summary
A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental 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
- Labor Long
- What is being tested?
- Support from a trained companion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 1 siteUganda
- Study dates
- 30 Dec 2019to 30 Aug 2021
- 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
- Women with a singleton fetus and a supposed cephalic presentation.
- Women with a female friend or relative willing to stay with them through the process of labor and birth.
Who cannot join
- Women with a multiple pregnancy.
- Women with a previous cesarean section
- Women who are mentally incapacitated or deaf and dumb
Trial locations and contacts
1 site in 1 country.
Eva Wodeya Wanyenze, Master of Nursing (Midwifery) contact
Uganda1 site, 1 recruiting
- Recruiting
Mbale Regional Referral Hospital
Mbale, +256
Kenneth Mugabe
About this study
A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.
Read the detailed description
The order of introduction of the intervention will be determined randomly. Control data will be obtained from the first health facility until the sample size for the control for that facility is achieved. Following collection of control data for the first facility, the intervention will be introduced to the same facility to a new group of participants. Simultaneously control data from the other facilities will be collected and this will be done until all the facilities are covered in a step wedge manner.
The intervention will consist of a session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed.
- Conditions
- Labor Long
- Being tested
- Support from a trained companion
- Keywords
- Support, companion,labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support from a trained companionBehavioural
Birth companions trained on how to effectively support women during labor
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Women are normally escorted to the health facilities by one or more family members and or friends. Women usually labor in an open first stage room where more than one woman is admitted sometimes with curtains to separate the beds with one person allowed besides her to provide support. The support persons do not have designated roles to play during this process. Routine analgesia is not given neither is continuous fetal monitoring. Midwives, Receives: Behavioral: Support from a trained companion |
| Arm 2 | Experimental | One session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed Receives: Behavioral: Support from a trained companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a Spontaneous Vaginal delivery
delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section
Measured: labour duration
Secondary outcomes (5)
coping and anxiety
Women's self-reported anxiety on admission and after birth will be measured using the 10 cm Visual Analogue Scales Coping with labour will be assessed using the Roberts coping with labour algorithm the midwife looks out for cues for coping and not coping
Measured: labour duration
Length of labour
From time of admission (4-6cm) to birth
Measured: labour duration
Apgar score
Apgar score of baby at birth
Measured: At 1 and 5 minutes
use of oxytocin to augment labor
Use of oxytocin to augment labor
Measured: labor duration
Maternal satisfaction questionnaire
Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience
Measured: Labour duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start30 Dec 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
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 LongStudies 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
- Sequential
- Model description
- Educational; training of lay persons on support during labour
- Masking
- None (open label)
- Enrolment
- 535 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Responsible party
- Sponsor
- Investigators
- Gorrette Nalwadda, PhD, Study chair, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771325
- Sponsor's protocol ID
- 2017-54
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wanyenze EW, Nalwadda GK, Tumwesigye NM, Byamugisha JK. Efficacy of midwife-led role orientation of birth companions on maternal satisfaction and birth outcomes: a randomized control trial in Uganda. BMC Pregnancy Childbirth. 2023 Sep 18;23(1):669. doi: 10.1186/s12884-023-05978-8.
PubMed 37723430
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda
- ClinicalTrials.gov ID
- NCT04771325
- Acronym / sponsor ID
- 2017-54
- Conditions
- Labor Long
- Keywords
- Support, companion,labour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 535 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 25 Feb 2021 (actual)
- 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.
A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.
Detailed description
The order of introduction of the intervention will be determined randomly. Control data will be obtained from the first health facility until the sample size for the control for that facility is achieved. Following collection of control data for the first facility, the intervention will be introduced to the same facility to a new group of participants. Simultaneously control data from the other facilities will be collected and this will be done until all the facilities are covered in a step wedge manner.
The intervention will consist of a session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Educational; training of lay persons on support during labour
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Support from a trained companionWomen are normally escorted to the health facilities by one or more family members and or friends. Women usually labor in an open first stage room where more than one woman is admitted sometimes with curtains to separate the beds with one person allowed besides her to provide support. The support persons do not have designated roles to play during this process. Routine analgesia is not given neither is continuous fetal monitoring. Midwives, |
| Arm 2 | Experimental | Behavioral: Support from a trained companionOne session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women with a singleton fetus and a supposed cephalic presentation.
- Women with a female friend or relative willing to stay with them through the process of labor and birth.
Key exclusion criteria (3 listed)
- Women with a multiple pregnancy.
- Women with a previous cesarean section
- Women who are mentally incapacitated or deaf and dumb
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 |
|---|---|---|
| Support from a trained companionBirth companions trained on how to effectively support women during labor | Behavioural | Arm 1, Arm 2 |
Primary outcome
Incidence of a Spontaneous Vaginal delivery
Time frame: labour duration
delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section
5 secondary outcomes
coping and anxiety
Time frame: labour duration
Length of labour
Time frame: labour duration
Apgar score
Time frame: At 1 and 5 minutes
use of oxytocin to augment labor
Time frame: labor duration
Maternal satisfaction questionnaire
Time frame: Labour duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 37723430Wanyenze EW, Nalwadda GK, Tumwesigye NM, Byamugisha JK. Efficacy of midwife-led role orientation of birth companions on maternal satisfaction and birth outcomes: a randomized control trial in Uganda. BMC Pregnancy Childbirth. 2023 Sep 18;23(1):669. doi: 10.1186/s12884-023-05978-8.
- Individual participant dataSharing planned: Undecided
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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.
Eva Wodeya Wanyenze, Master of Nursing (Midwifery) contact
Gorrette Nalwadda, PhD study chair
Makerere 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 Support from a trained companion in people with Labor Long, run by Makerere University at 1 site in Uganda.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Wodeya Wanyenze, Master of Nursing (Midwifery) (256772651333 ext. +256772651333, ewanyenze@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a Spontaneous Vaginal delivery (time frame: labour duration). 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 NCT04771325, 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 25 Feb 2021.