Labor ComfortLCGNCT07686419
Labor Care Guide Application
A study testing labor care guide in people with Labor Comfort, run by Ain Shams University at 1 site in Egypt.
Trial summary
Application of the WHO Labor Care Guide in Ain Shams university Maternity hospital demonstrates high healthcare provider acceptability and improves labor progression, increases vaginal delivery rates, and reduces selected maternal complications without adversely affecting neonatal outcomes. Read more about this study
- Who is it for?
- Ages 15 to 45 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Comfort
- What is being tested?
- labor care guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Aug 2025
- 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 15 to 45 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Pregnant woman who will undergo vaginal delivery at Ain Shams University Maternity Hospital with gestational age above or equal 37 weeks
- Vertex presentation .
- Women with estimated fetal weight 2.5 till 4 kg
Who cannot join
- Placenta previa
- Placenta previa accreta
- Macrosomic baby above 4 kg in diabetic women and above 4.5 kg in non diabetic women
- Placenta abruption complicated by non reassuring CTG or life threatening bleeding
- Cord prolapse
- Vasa previa
Show all 9Show fewer
- Primary active genital herpes simplex
- Patient with anemia which may lead to atonic uterus and prolonged labor.
- Women with previously scarred uterus due to risk of ruptured uterus and postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
Application of the WHO Labor Care Guide in Ain Shams university Maternity hospital demonstrates high healthcare provider acceptability and improves labor progression, increases vaginal delivery rates, and reduces selected maternal complications without adversely affecting neonatal outcomes.
Read the detailed description
The Labor Care Guide (LCG) is a tool developed by the World Health Organization (WHO) to support evidence-based, woman-centered intrapartum care and improve labor monitoring. It was introduced as an alternative to the traditional partograph, aiming to facilitate timely clinical decision-making and enhance the quality of maternity care.
This randomized controlled trial was conducted at Ain Shams University Maternity Hospital to evaluate the effect of the WHO Labor Care Guide on maternal and neonatal outcomes among women undergoing vaginal delivery. Eligible pregnant women were randomly assigned to one of two groups: a study group monitored using the WHO Labor Care Guide and a control group monitored using the modified WHO partograph.
Participants underwent routine obstetric assessment and monitoring throughout labor according to the allocated monitoring tool. Maternal outcomes assessed included labor progression, mode of delivery, and intrapartum and postpartum complications. Neonatal outcomes included neonatal well-being, need for neonatal intensive care admission, and neonatal complications. Healthcare provider satisfaction with the labor monitoring tool was also evaluated.
The study aimed to compare the effectiveness of the WHO Labor Care Guide with the modified WHO partograph in supporting labor management and improving maternal and neonatal care.
- Conditions
- Labor Comfort
- Being tested
- labor care guide
- Keywords
- labor care guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labor care guideDevice
labor monitoring tool
| Study group | Role | What they receive |
|---|---|---|
| Labor care guide | Experimental | Intervensional study Receives: Device: labor care guide |
| partogrph | No intervention | no intervension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
Measured using a 5-point Likert scale. Range: 1-5. Higher scores indicate greater satisfaction.
Measured: assessed at 6 months
Secondary outcomes (6)
Mode of delivery
The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)
Measured: At delivery
Duration of active labor
The total duration of the active phase of labor, measured in hours.
Measured: At delivery
Incidence of maternal complications
The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).
Measured: assessed at 6 weeks postpartum
Incidence of neonatal complications
The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).
Measured: At delivery
Duration of hospital stay
The total number of days the mother and/or neonate remained hospitalized from admission to discharge.
Measured: from birth until hospital discharge average 2 to 3 days
Neonatal Outcomes via Apgar Score and NICU Admission
Neonatal well-being will be assessed using the Apgar score at 5 minutes (ranging from 0 to 10, where higher scores indicate better neonatal health) and the rate of admission to the Neonatal Intensive Care Unit (NICU).
Measured: from birth until hospital discharge average 2 to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComfortStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686419
- Sponsor's protocol ID
- MS459
- Acronym
- LCG
- Status last verified
- Aug 2025
- First submitted
- 10 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07686419
- Acronym / sponsor ID
- LCG / MS459
- Conditions
- Labor Comfort
- Keywords
- labor care guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 7 Jul 2026 (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.
Application of the WHO Labor Care Guide in Ain Shams university Maternity hospital demonstrates high healthcare provider acceptability and improves labor progression, increases vaginal delivery rates, and reduces selected maternal complications without adversely affecting neonatal outcomes.
Detailed description
The Labor Care Guide (LCG) is a tool developed by the World Health Organization (WHO) to support evidence-based, woman-centered intrapartum care and improve labor monitoring. It was introduced as an alternative to the traditional partograph, aiming to facilitate timely clinical decision-making and enhance the quality of maternity care.
This randomized controlled trial was conducted at Ain Shams University Maternity Hospital to evaluate the effect of the WHO Labor Care Guide on maternal and neonatal outcomes among women undergoing vaginal delivery. Eligible pregnant women were randomly assigned to one of two groups: a study group monitored using the WHO Labor Care Guide and a control group monitored using the modified WHO partograph.
Participants underwent routine obstetric assessment and monitoring throughout labor according to the allocated monitoring tool. Maternal outcomes assessed included labor progression, mode of delivery, and intrapartum and postpartum complications. Neonatal outcomes included neonatal well-being, need for neonatal intensive care admission, and neonatal complications. Healthcare provider satisfaction with the labor monitoring tool was also evaluated.
The study aimed to compare the effectiveness of the WHO Labor Care Guide with the modified WHO partograph in supporting labor management and improving maternal and neonatal care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor care guide | Experimental | Device: labor care guideIntervensional study |
| partogrph | No intervention | –no intervension |
Who may qualify
- Ages
- 15 to 45 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pregnant woman who will undergo vaginal delivery at Ain Shams University Maternity Hospital with gestational age above or equal 37 weeks
- Vertex presentation .
- Women with estimated fetal weight 2.5 till 4 kg
Key exclusion criteria (9 listed)
- Placenta previa
- Placenta previa accreta
- Macrosomic baby above 4 kg in diabetic women and above 4.5 kg in non diabetic women
- Placenta abruption complicated by non reassuring CTG or life threatening bleeding
- Cord prolapse
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 |
|---|---|---|
| labor care guidelabor monitoring tool | Device | Labor care guide |
Primary outcome
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
Time frame: assessed at 6 months
Measured using a 5-point Likert scale. Range: 1-5. Higher scores indicate greater satisfaction.
6 secondary outcomes
Mode of delivery
Time frame: At delivery
Duration of active labor
Time frame: At delivery
Incidence of maternal complications
Time frame: assessed at 6 weeks postpartum
Incidence of neonatal complications
Time frame: At delivery
Duration of hospital stay
Time frame: from birth until hospital discharge average 2 to 3 days
Neonatal Outcomes via Apgar Score and NICU Admission
Time frame: from birth until hospital discharge average 2 to 3 days
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Labor Comfort
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Using Wet Towel During Labor
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Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period
Pain Management, Birth Comfort
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing labor care guide in people with Labor Comfort, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 9 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 7 Jul 2026. 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 Egypt. 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?
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ) (time frame: assessed at 6 months). 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 7 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.