Postpartum HemorrhageUTAMPNCT02223806
Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
A study testing Uterine Tonus Assessment by Midwife and Patient self-assessment of uterine tonus in people with Postpartum Hemorrhage, run by UMC Utrecht at 1 site in Ghana.
Trial summary
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Uterine Tonus Assessment by Midwife and Patient self-assessment of uterine tonus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteGhana
- Study dates
- Apr 2014to Aug 2015
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years
- Be in labor with an expected vaginal delivery, as assessed by the midwives
- Gestation age ≥ 37 weeks
- Received antenatal instructions on postnatal uterine tonus assessment
- Provided informed consent.
Who cannot join
- Age <18
- Elective caesarean delivery
- Severe anemia (<8g/dL)
- Placenta praevia
- Anticipated breech delivery
- Referred patients who have not received antenatal care (ANC) uterine tonus assessment instructions
- Multiple Pregnancy
- Intra uterine fetal death
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.
Read the detailed description
Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of health professionals understaffed hospitals in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterine tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated.
Objective: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss, and other maternal and neonatal outcomes.
Study design: Randomized intervention study. Study population: Pregnant women admitted in the labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control group will continue the current practice of self-assessment after patient education with regular monitoring of midwives.
Main study parameters/endpoints: post-partum haemorrhage (>500 ml blood loss), severe postpartum haemorrhage (>1000 ml blood loss), mean blood loss, other maternal and neonatal outcomes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the standard of midwifery and obstetric care, and will have access to emergency obstetric interventions. All steps of the AMTSL will be performed, with the exemption of the last step of uterine tonus assessment for which women will be randomized to receive the intervention or current practice of care. Risk associated with the intervention are discomfort because of an external assessment. Data will be obtained from record books at the ward. Women will be asked for informed consent prior to participation. This study will be approved by the Ethical en Protocol Review Committee of the University of Ghana Medical School and the Medical Ethical Research Committee of the University Medical Center Utrecht.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Uterine Tonus Assessment by Midwife, Patient self-assessment of uterine tonus
- Keywords
- Postpartum hemorrhage, Uterine tonus assessment, Active management of third stage of labor
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Tonus Assessment by MidwifeBehavioural
Uterine tonus assessment every 15 minutes for 2 hours.
Patient self-assessment of uterine tonusBehavioural
Uterine tonus assessment by patient every 15 minutes for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Self-assessment of uterine tonus | Active comparator | Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care. Receives: Behavioral: Patient self-assessment of uterine tonus |
| Midwife uterine tonus assessment | Experimental | Uterine tonus assessment every 15 minutes for 2 hours by midwive. Receives: Behavioral: Uterine Tonus Assessment by Midwife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage (>500 ml blood loss)
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.
Measured: within 24 hours postpartum
Secondary outcomes (5)
Mean blood loss (in ml)
Measured: Within 24 hours postpartum
Severe post-partum hemorrhage
>1000ml blood loss
Measured: Within 24 hours postpartum
Use of additional uterotonics
Measured: Within 24 hours postpartum
Use of other procedures for management of postpartum hemorrhage
I.e. surgery, manual placenta tissue removal
Measured: Within 24 hours postpartum
Late postpartum hemorrhage
Based on readmission
Measured: From 24 hours and upto one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionAug 2015
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 Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, University of Ghana
- Responsible party
- Principal investigator, Joyce L. Browne, UMC Utrecht
- Investigators
- Joyce L Browne, MD, MSc, Principal investigator, UMC Utrecht, the NetherlandsKerstin D Klipstein-Grobusch, PhD MSc, Principal investigator, University Medical Center Utrecht, The NetherlandsNelson Damale, MBChB, Principal investigator, Korle-Bu Teaching Hospital, Accra, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223806
- Sponsor's protocol ID
- UMC-GH 002
- Acronym
- UTAMP
- Status last verified
- Nov 2016
- First submitted
- 11 Aug 2014
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Browne JL, Damale NK, Raams TM, Van der Linden EL, Maya ET, Doe R, Rijken MJ, Adanu R, Grobbee DE, Franx A, Klipstein-Grobusch K. Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial. Trials. 2015 Dec 18;16:580. doi: 10.1186/s13063-015-1111-5.
PubMed 26683621
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
- ClinicalTrials.gov ID
- NCT02223806
- Acronym / sponsor ID
- UTAMP / UMC-GH 002
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Uterine tonus assessment, Active management of third stage of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, University of Ghana
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Aug 2014 (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.
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.
Detailed description
Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of health professionals understaffed hospitals in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterine tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated.
Objective: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss, and other maternal and neonatal outcomes.
Study design: Randomized intervention study. Study population: Pregnant women admitted in the labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control group will continue the current practice of self-assessment after patient education with regular monitoring of midwives.
Main study parameters/endpoints: post-partum haemorrhage (>500 ml blood loss), severe postpartum haemorrhage (>1000 ml blood loss), mean blood loss, other maternal and neonatal outcomes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the standard of midwifery and obstetric care, and will have access to emergency obstetric interventions. All steps of the AMTSL will be performed, with the exemption of the last step of uterine tonus assessment for which women will be randomized to receive the intervention or current practice of care. Risk associated with the intervention are discomfort because of an external assessment. Data will be obtained from record books at the ward. Women will be asked for informed consent prior to participation. This study will be approved by the Ethical en Protocol Review Committee of the University of Ghana Medical School and the Medical Ethical Research Committee of the University Medical Center Utrecht.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-assessment of uterine tonus | Active comparator | Behavioral: Patient self-assessment of uterine tonusUterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care. |
| Midwife uterine tonus assessment | Experimental | Behavioral: Uterine Tonus Assessment by MidwifeUterine tonus assessment every 15 minutes for 2 hours by midwive. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Be in labor with an expected vaginal delivery, as assessed by the midwives
- Gestation age ≥ 37 weeks
- Received antenatal instructions on postnatal uterine tonus assessment
- Provided informed consent.
Key exclusion criteria (8 listed)
- Age <18
- Elective caesarean delivery
- Severe anemia (<8g/dL)
- Placenta praevia
- Anticipated breech 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 |
|---|---|---|
| Uterine Tonus Assessment by MidwifeUterine tonus assessment every 15 minutes for 2 hours. | Behavioural | Midwife uterine tonus assessment |
| Patient self-assessment of uterine tonusUterine tonus assessment by patient every 15 minutes for 2 hours. | Behavioural | Self-assessment of uterine tonus |
Primary outcome
Postpartum hemorrhage (>500 ml blood loss)
Time frame: within 24 hours postpartum
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.
5 secondary outcomes
Mean blood loss (in ml)
Time frame: Within 24 hours postpartum
Severe post-partum hemorrhage
Time frame: Within 24 hours postpartum
Use of additional uterotonics
Time frame: Within 24 hours postpartum
Use of other procedures for management of postpartum hemorrhage
Time frame: Within 24 hours postpartum
Late postpartum hemorrhage
Time frame: From 24 hours and upto one week
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 25 Nov 2016.
- Derived from this study: PubMed 26683621Browne JL, Damale NK, Raams TM, Van der Linden EL, Maya ET, Doe R, Rijken MJ, Adanu R, Grobbee DE, Franx A, Klipstein-Grobusch K. Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial. Trials. 2015 Dec 18;16:580. doi: 10.1186/s13063-015-1111-5.
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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.
Joyce L Browne, MD, MSc principal investigator
UMC Utrecht, the Netherlands
Kerstin D Klipstein-Grobusch, PhD MSc principal investigator
University Medical Center Utrecht, The Netherlands
Nelson Damale, MBChB principal investigator
Korle-Bu Teaching Hospital, Accra, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Tonus Assessment by Midwife and Patient self-assessment of uterine tonus in people with Postpartum Hemorrhage, run by UMC Utrecht at 1 site in Ghana.
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 8 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 25 Nov 2016. 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 Ghana. 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?
Postpartum hemorrhage (>500 ml blood loss) (time frame: within 24 hours postpartum). 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 NCT02223806, 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 Nov 2016.