Labor and DeliveryNCT07445373
Role of the WHO Labour Care Guide in Improving Maternal and Fetal Outcomes
A study testing Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) in people with Labor and Delivery, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to compare the effectiveness of WHO labour care guide (LCG) with the WHO modified partogragh in improving the maternal and fetal outcomes among primigravida and multigravida in active labour .the study evaluates whether use of the Labour care guide leads to improved… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Labor and Delivery
- What is being tested?
- Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patient aged 20 to 40 years .
- gestational age 37 to 42 weeks as per LMP.
- parity UpTo 4
- singketon pregnancy on ultrasound
- patient presenating In labor as per operational definitons
Who cannot join
- patients with breech presenation
- pregnant women in whom trial of labor given outside the hospital,
- women with complications like gestational diabetes,antepartum hemorrhage,severe preeclampsia/eclampsia and medical disorders complicating the pregnancy
- premature rupture of membranes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of WHO Labour Care Guide in Improving Maternal and Fetal Outcomes in Primi and Multigravida in Labour
The goal of this randomized controlled trial is to compare the effectiveness of WHO labour care guide (LCG) with the WHO modified partogragh in improving the maternal and fetal outcomes among primigravida and multigravida in active labour .the study evaluates whether use of the Labour care guide leads to improved labour monitoring ,timely clinical decision making and better maternal and neonatal outcomes .this study will answer either of the two questions that is
- There is no difference in maternal and fetal outcomes between women monitored with Wo labour care guide (LCG) and those monitored with the Modified Partogragh
- There is a difference in maternal and fetal outcomes between women monitored with the WHO Labour care guide (LCG) and those monitored the modified Partogragh .
Read the detailed description
The WHO labour care guide is newer tool to designed in 2020 to replace the replace the traditional modified partogragh for monitoring labor and to improve the quality of intrapartum care .It focuses on evidence based and respectful maternity care and clinical decision making .This trial will b conducted in a tertiary care hospital (KTH Peshawar ) and will include women in active labor who meet the criteria .
The participant who are eligible will be randomly allocated in to two groups : one will be monitored using the WHO labour Care guide and the other monitored using modified Partogragh .maternal outcomes such as duration of labour ,mode of delivery ,need for labor augmentation and maternal complications will be assessed.Fetal and neonatal outcomes including Apgar score, need for neonatal resuscitation ,need for NICU admission ,and perinatal morbidity will also be assessed..
The study will aim to determine whether the Labour care guide provide superior clinical outcomes compared to the modified partogragh in both primigravida and multigravida women.
- Conditions
- Labor and Delivery
- Being tested
- Group A (Intervention Arm): Monitoring with WHO Labour Care Guide), Group B (Control Arm): Monitoring with Standard WHO Partograph)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)Other
Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) Women randomized to Group A will be monitored using the World Health Organization Labour Care Guide (LCG) as the intrapartum monitoring tool.
The LCG incorporates evidence-based, individualized labour progress thresholds and emphasizes comprehensive maternal and fetal assessment. The following parameters will be recorded at recommended intervals:
Cervical dilatation and labour progress Fetal heart rate Uterine contractions Maternal vital signs (pulse, blood pressure, temperature) Assessment of amniotic fluid Supportive care measures (oral intake, mobility, pain relief) Respectful maternity care indicators Clinical reassessment prompts embedded within the LCG will guide decision-making. No traditional alert or action lines will be used; instead, management will be individualized based on dynamic clinical assessment.
Group B (Control Arm): Monitoring with Standard WHO Partograph)Other
Women randomized to Group B will be monitored using the standard WHO-modified partograph as the intrapartum monitoring tool.
The partograph will include:
Cervical dilatation plotted against time Fetal heart rate monitoring Uterine contractions Maternal vital signs Status of membranes and liquor Labour progress will be assessed using the traditional alert and action lines, and clinical decisions (augmentation or operative intervention) will be taken according to institutional protocol based on partographic findings.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will be monitored using the WHO Labour Care Guide (LCG) for Intrapartum assessment and clinical decision-making from the active phase of labour until delivery. Receives: Other: Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) |
| Group B | Active comparator | group B will be monitored using the WHO Modified Partograph for documentation and assessment of labor progress, maternal condition, and fetal well-being until delivery. Receives: Other: Group B (Control Arm): Monitoring with Standard WHO Partograph) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labour
Total duration of labour measured from admission in active labour to delivery (in hours)
Measured: From admission in active labour until delivery
Secondary outcomes (4)
Mode of delivery
Mode of delivery categorized as spontaneous vaginal delivery, operative vaginal delivery, or caesarean section
Measured: )At the time of delivery
Neonatal condition at birth
Assessed by apgar score at 1 and 5 min and need for neonatal resuscitation
Measured: At birth and within 5 min after delivery
Neonatal intensive care unit admission (NICU)
Admission to NICU for any indication
Measured: Within 24 hours after birth
Intrapartum maternal complications
Occurrence of postpartum hemorrhage ,uterine rupture ,fetal distress
Measured: During labour and immediate portpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor and DeliveryStudies 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
- Parallel groups
- Model description
- Participants will be randomly assigned to either the Labour Care Guide group or the WHO modified partograph group.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roshni Mumtaz, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445373
- Sponsor's protocol ID
- 549/DME/KMC
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tolu LB, Jeldu WG, Feyissa GT. Effectiveness of utilizing the WHO safe childbirth checklist on improving essential childbirth practices and maternal and perinatal outcome: A systematic review and meta-analysis. PLoS One. 2020 Jun 12;15(6):e0234320. doi: 10.1371/journal.pone.0234320. eCollection 2020.
PubMed 32530940Sama CB, Takah NF, Danwe VK, Melo UF, Dingana TN, Angwafo FF 3rd. Knowledge and utilization of the partograph: A cross-sectional survey among obstetric care providers in urban referral public health institutions in northwest and southwest Cameroon. PLoS One. 2017 Feb 24;12(2):e0172860. doi: 10.1371/journal.pone.0172860. eCollection 2017.
PubMed 28234990Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
PubMed 28681500Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.
PubMed 30080256Vogel JP, Pujar Y, Vernekar SS, Armari E, Pingray V, Althabe F, Gibbons L, Berrueta M, Somannavar M, Ciganda A, Rodriguez R, Bendigeri S, Kumar JA, Patil SB, Karinagannanavar A, Anteen RR, Mallappa Ramachandrappa P, Shetty S, Bommanal L, Haralahalli Mallesh M, Gaddi SS, Chikkagowdra S, Raghavendra B, Homer CSE, Lavender T, Kushtagi P, Hofmeyr GJ, Derman R, Goudar S. Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial. Nat Med. 2024 Feb;30(2):463-469. doi: 10.1038/s41591-023-02751-4. Epub 2024 Jan 30.
PubMed 38291297Pandey D, Bharti R, Dabral A, Khanam Z. Impact of WHO Labor Care Guide on reducing cesarean sections at a tertiary center: an open-label randomized controlled trial. AJOG Glob Rep. 2022 Jul 20;2(3):100075. doi: 10.1016/j.xagr.2022.100075. eCollection 2022 Aug.
PubMed 36276791Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.
PubMed 33225484Maaloe N, van Roosmalen J, Dmello B, Kwast B, van den Akker T, Housseine N, Kujabi M, Meguid T, Kidanto H. WHO next-generation partograph: revolutionary steps towards individualised labour care? BJOG. 2022 Apr;129(5):682-684. doi: 10.1111/1471-0528.16914. Epub 2021 Sep 28. No abstract available.
PubMed 34520112
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of WHO Labour Care Guide in Improving Maternal and Fetal Outcomes in Primi and Multigravida in Labour
- ClinicalTrials.gov ID
- NCT07445373
- Acronym / sponsor ID
- 549/DME/KMC
- Conditions
- Labor and Delivery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Mar 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.
The goal of this randomized controlled trial is to compare the effectiveness of WHO labour care guide (LCG) with the WHO modified partogragh in improving the maternal and fetal outcomes among primigravida and multigravida in active labour .the study evaluates whether use of the Labour care guide leads to improved labour monitoring ,timely clinical decision making and better maternal and neonatal outcomes .this study will answer either of the two questions that is
- There is no difference in maternal and fetal outcomes between women monitored with Wo labour care guide (LCG) and those monitored with the Modified Partogragh
- There is a difference in maternal and fetal outcomes between women monitored with the WHO Labour care guide (LCG) and those monitored the modified Partogragh .
Detailed description
The WHO labour care guide is newer tool to designed in 2020 to replace the replace the traditional modified partogragh for monitoring labor and to improve the quality of intrapartum care .It focuses on evidence based and respectful maternity care and clinical decision making .This trial will b conducted in a tertiary care hospital (KTH Peshawar ) and will include women in active labor who meet the criteria .
The participant who are eligible will be randomly allocated in to two groups : one will be monitored using the WHO labour Care guide and the other monitored using modified Partogragh .maternal outcomes such as duration of labour ,mode of delivery ,need for labor augmentation and maternal complications will be assessed.Fetal and neonatal outcomes including Apgar score, need for neonatal resuscitation ,need for NICU admission ,and perinatal morbidity will also be assessed..
The study will aim to determine whether the Labour care guide provide superior clinical outcomes compared to the modified partogragh in both primigravida and multigravida women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the Labour Care Guide group or the WHO modified partograph group.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)Group A will be monitored using the WHO Labour Care Guide (LCG) for Intrapartum assessment and clinical decision-making from the active phase of labour until delivery. |
| Group B | Active comparator | Other: Group B (Control Arm): Monitoring with Standard WHO Partograph)group B will be monitored using the WHO Modified Partograph for documentation and assessment of labor progress, maternal condition, and fetal well-being until delivery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patient aged 20 to 40 years .
- gestational age 37 to 42 weeks as per LMP.
- parity UpTo 4
- singketon pregnancy on ultrasound
- patient presenating In labor as per operational definitons
Key exclusion criteria (4 listed)
- patients with breech presenation
- pregnant women in whom trial of labor given outside the hospital,
- women with complications like gestational diabetes,antepartum hemorrhage,severe preeclampsia/eclampsia and medical disorders complicating the pregnancy
- premature rupture of membranes
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 |
|---|---|---|
| Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) Women randomized to Group A will be monitored using the World Health Organization Labour Care Guide (LCG) as the intrapartum monitoring tool. The LCG incorporates evidence-based, individualized labour progress thresholds and emphasizes comprehensive maternal and fetal assessment. The following parameters will be recorded at recommended intervals: Cervical dilatation and labour progress Fetal heart rate Uterine contractions Maternal vital signs (pulse, blood pressure, temperature) Assessment of amniotic fluid Supportive care measures (oral intake, mobility, pain relief) Respectful maternity care indicators Clinical reassessment prompts embedded within the LCG will guide decision-making. No traditional alert or action lines will be used; instead, management will be individualized based on dynamic clinical assessment. | Other | Group A |
| Group B (Control Arm): Monitoring with Standard WHO Partograph)Women randomized to Group B will be monitored using the standard WHO-modified partograph as the intrapartum monitoring tool. The partograph will include: Cervical dilatation plotted against time Fetal heart rate monitoring Uterine contractions Maternal vital signs Status of membranes and liquor Labour progress will be assessed using the traditional alert and action lines, and clinical decisions (augmentation or operative intervention) will be taken according to institutional protocol based on partographic findings. | Other | Group B |
Primary outcome
Duration of labour
Time frame: From admission in active labour until delivery
Total duration of labour measured from admission in active labour to delivery (in hours)
4 secondary outcomes
Mode of delivery
Time frame: )At the time of delivery
Neonatal condition at birth
Time frame: At birth and within 5 min after delivery
Neonatal intensive care unit admission (NICU)
Time frame: Within 24 hours after birth
Intrapartum maternal complications
Time frame: During labour and immediate portpartum period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 32530940Tolu LB, Jeldu WG, Feyissa GT. Effectiveness of utilizing the WHO safe childbirth checklist on improving essential childbirth practices and maternal and perinatal outcome: A systematic review and meta-analysis. PLoS One. 2020 Jun 12;15(6):e0234320. doi: 10.1371/journal.pone.0234320. eCollection 2020.
- Background: PubMed 28234990Sama CB, Takah NF, Danwe VK, Melo UF, Dingana TN, Angwafo FF 3rd. Knowledge and utilization of the partograph: A cross-sectional survey among obstetric care providers in urban referral public health institutions in northwest and southwest Cameroon. PLoS One. 2017 Feb 24;12(2):e0172860. doi: 10.1371/journal.pone.0172860. eCollection 2017.
- Background: PubMed 28681500Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
- Background: PubMed 30080256Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.
- Background: PubMed 38291297Vogel JP, Pujar Y, Vernekar SS, Armari E, Pingray V, Althabe F, Gibbons L, Berrueta M, Somannavar M, Ciganda A, Rodriguez R, Bendigeri S, Kumar JA, Patil SB, Karinagannanavar A, Anteen RR, Mallappa Ramachandrappa P, Shetty S, Bommanal L, Haralahalli Mallesh M, Gaddi SS, Chikkagowdra S, Raghavendra B, Homer CSE, Lavender T, Kushtagi P, Hofmeyr GJ, Derman R, Goudar S. Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial. Nat Med. 2024 Feb;30(2):463-469. doi: 10.1038/s41591-023-02751-4. Epub 2024 Jan 30.
- Background: PubMed 36276791Pandey D, Bharti R, Dabral A, Khanam Z. Impact of WHO Labor Care Guide on reducing cesarean sections at a tertiary center: an open-label randomized controlled trial. AJOG Glob Rep. 2022 Jul 20;2(3):100075. doi: 10.1016/j.xagr.2022.100075. eCollection 2022 Aug.
- Background: PubMed 33225484Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.
- Background: PubMed 34520112Maaloe N, van Roosmalen J, Dmello B, Kwast B, van den Akker T, Housseine N, Kujabi M, Meguid T, Kidanto H. WHO next-generation partograph: revolutionary steps towards individualised labour care? BJOG. 2022 Apr;129(5):682-684. doi: 10.1111/1471-0528.16914. Epub 2021 Sep 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) in people with Labor and Delivery, run by Khyber Teaching Hospital at 1 site in Pakistan.
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 4 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: opening soon, as of the sponsor's last update on 3 Mar 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Roshni Mumtaz, MBBS (+923333765884, roshnimumtaz1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of labour (time frame: From admission in active labour until 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 NCT07445373, which also lists 8 linked publications.
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 3 Mar 2026.