Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604495045431 Date of Registration: 21/04/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Hospital-Based Randomized Controlled Trial — Comparing the Outcome of Delivery Between Upright (All Fours) and Supine Positions During Second Stage of Labour in Specialist Hospital, Owerri, Imo State, Nigeria.
Official scientific title Maternal and newborn outcome of upright (All Fours’) versus supine birthing positions in second stage in labouring women in Owerri using a randomized control trial
Brief summary describing the background and objectives of the trial Background and rationale Position during the second stage of labour affects maternal comfort, biomechanics of labour, fetal head engagement, duration of second stage and potentially maternal and neonatal outcomes. While supine/lithotomy positions are common in many hospitals, evidence suggests upright positions (including all-fours) may shorten the second stage, reduce assisted deliveries, and improve maternal comfort. Childbirth is a significant physiological process, and the position a woman adopts during labor and delivery can have a profound effect on both maternal and neonatal outcomes. However, high-quality randomized evidence in the Nigerian setting (regional care practices, staffing, and cultural preferences) is limited. This randomized trial will provide locally relevant evidence to inform midwifery practice in the study region. The aim of the study is to compare the maternal and neonatal outcomes of normal deliveries between women who adopt upright (All fours) birthing positions and those who use supine positions during second stage of labor. Objectives 1. To evaluate the duration of labor between nulliparous women who adopt upright positions and those who use supine positions during second stage. 2. To assess the level of maternal comfort and satisfaction during delivery in upright versus supine positions in Nulliparous women during second stage. 3. To compare the incidence of medical interventions (e.g., episiotomy, assisted delivery, and use of oxytocin) between women in upright and supine positions during labor. 4. To examine the neonatal outcomes, including Apgar scores and birth weight, associated with upright and supine birthing positions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HBRCTCODBUPDSSL
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Comparing Birthing Positions during second stage of normal labour
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 23/03/2026
Actual trial start date 06/04/2026
Anticipated date of last follow up 04/03/2026
Actual Last follow-up date 20/04/2027
Anticipated target sample size (number of participants) 245
Actual target sample size (number of participants) 170
Recruitment status Recruiting
Publication URL https://sciencescholar.us/journal/index.php/ijhs/article/view/15788 https://internationaljournalcorner.com/index.php/ijird_ojs/search/authors/view?givenName=Egeh%20Perpetual&familyName=Chinasa&affiliation=&country=&authorName=Chinasa%2C%20Egeh%20Per
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group supine position Participants assigned to the control group will remain in the supine or semi-recumbent position during the second stage of labour until delivery of the baby, following routine obstetric practice in the facility The control will be applied throughout the second stage of labour, beginning from full cervical dilatation (10 cm) until the delivery of the baby and placenta. Control Group (Supine Position): Participants randomized to the control group will deliver in the supine or semi-recumbent position, which is the routine practice in many hospital settings. In this position, the woman lies on her back on the delivery bed with her knees flexed and legs supported by the delivery table or assistants. Standard obstetric care, including monitoring of maternal and fetal wellbeing and guidance for pushing during contractions, will be provided by the attending midwives 85 Active-Treatment of Control Group
Experimental Group upright position The dose of the intervention is defined as continuous or predominant adoption of the upright (all-fours) position during the second stage of labour. Participants will be encouraged to maintain this position from full cervical dilatation (10 cm) until delivery of the baby. Short position adjustments may be allowed for comfort; however, the participant will remain predominantly in the upright posture. he intervention will be applied throughout the second stage of labour, beginning from full cervical dilatation (10 cm) until the delivery of the baby and placenta. ntervention Group (Upright / All-Fours Position): Participants randomized to the intervention group will assume and maintain an upright all-fours maternal position during the second stage of labour. In this position, the woman supports her body with both hands and knees on the delivery bed, maintaining an elevated trunk and forward-leaning posture. Midwives will assist the participants in adopting and maintaining the position, ensuring comfort and safety. The woman will be encouraged to push spontaneously with uterine contractions while remaining in the upright posture. Position changes within the upright posture (e.g., kneeling or leaning forward) may be allowed for comfort, provided the trunk remains upright. Continuous maternal and fetal monitoring will be conducted according to standard obstetric care 85
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants included primigravida and multigravida women between 37 and 41 weeks of gestation with low-risk pregnancies who met the following criteria: - Spontaneous onset of labour, induction, or augmentation - Fetus in cephalic presentation - Reassuring fetal heart rate - Adequate pelvis on clinical pelvimetry - Willingness to provide informed consent - Singleton pregnancy - No major medical or obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa) - No history of previous caesarean section - Maternal age 18–44 years • Multiple pregnancy, non-cephalic presentation. • Known obstetric complications that mandate specific positioning or operative delivery (e.g., placenta praevia, cord prolapse). • Severe preeclampsia/eclampsia, active cardiac disease, or other maternal conditions where upright positioning is contraindicated. • Fetal distress at the time of randomization requiring immediate delivery. • Women who decline randomization • Women below 18 years and above 45years. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2025 Specialist Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
umuguma Owerri 460281 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome • Mode of delivery: spontaneous vaginal, instrumental (forceps/vacuum), emergency cesarean. • Maternal: perineal trauma (graded 1–4), need for episiotomy, postpartum haemorrhage (blood loss estimate >500 ml), maternal pain score during second stage (validated scale, e.g., Visual Analogue Scale 0–10), maternal satisfaction (postnatal questionnaire within 24–48h). • Neonatal: Apgar score at 1 and 5 minutes; requirement for bag-mask ventilation or advanced resuscitation; NICU admission within 24 hours; birthweight; perinatal morbidity (birth trauma). • Adverse events: maternal falls, cord prolapse, shoulder dystocia, any unexpected serious adverse event (SAE) requiring transfer. Measured to nearest minute after head of the baby is out
Primary Outcome The primary outcome is the time (in minutes) from full cervical dilatation (10 cm) to the delivery of the baby. This will be measured using a standard obstetric timer by the attending midwife or researcher. The duration will be compared between the upright (all-fours) position group and the supine position group to determine whether maternal positioning influences the length of the second stage of labour. From full cervical dilatation until birth of the neonate.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Specialist Hospital in Imo State Nigeria umuguma street Owerri 460281 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Claretian University of Nigeria Number 8 Nekede road owerri 46262 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Claretian University of Nigeria Management Number 8 Nekede Owerri 460262 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
The study hospital where the research is conducted Imo State Specialist Hospital Umuguma owerri 460281 Nigeria
Claretian University of Nigeria Nekede owerri 460282 Nigeria
Department of Obstetrics and Gynaecology umuguma owerri 460281 Nigeria
ACEPUTOR Uniport my study university choba port harcourt 500102 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EGEH PERPETUA CHINASA chinasaram2005@gmail.com +2348087698100 Nekede
City Postal code Country Position/Affiliation
Owerri 460262 Nigeria PhD Midwifery student
Role Name Email Phone Street address
Public Enquiries Lekpa David chinasaram2005@gmail.com 2348035607640 choba
City Postal code Country Position/Affiliation
portharcourt 500102 Nigeria General enquiries
Role Name Email Phone Street address
Scientific Enquiries Diorgu Faith faith.dirogu@uniport.edu.ng +2348033401555 Choba
City Postal code Country Position/Affiliation
Port harcourt 500102 Nigeria Scientific Enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) collected during this study will include demographic characteristics, obstetric history, duration of labour, maternal comfort and satisfaction scores, and maternal and neonatal outcomes. De-identified data may be shared with qualified researchers upon reasonable request for purposes of scientific research, secondary analysis, or verification of study findings, provided that participant confidentiality is strictly maintained and approval is obtained from the relevant ethics committee. Informed Consent Form,Statistical Analysis Plan,Study Protocol Individual participant data will be available beginning 6 months after publication of the primary results and ending 5 years after publication, upon reasonable request to the principal investigator. Access to de-identified individual participant data will be granted to qualified researchers with a scientifically sound research proposal. Requests must be submitted to the principal investigator and may require approval from the relevant institutional ethics committee. Data will only be shared for academic or scientific research purposes, and researchers must agree to maintain confidentiality and not attempt to identify study participants
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No external data repository link available. No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 23/03/2026 I was asked to add more detailed information Background and rationale Position during the second stage of labour affects maternal comfort, biomechanics of labour, fetal head engagement, duration of second stage and potentially maternal and neonatal outcomes. While supine/lithotomy positions are common in many hospitals, evidence suggests upright positions (including all-fours) may shorten the second stage, reduce assisted deliveries, and improve maternal comfort. Childbirth is a significant physiological process, and the position a woman adopts during labor and delivery can have a profound effect on both maternal and neonatal outcomes. However, high-quality randomized evidence in the Nigerian setting (regional care practices, staffing, and cultural preferences) is limited. This randomized trial will provide locally relevant evidence to inform midwifery practice in the study region. Background and rationale Position during the second stage of labour affects maternal comfort, biomechanics of labour, fetal head engagement, duration of second stage and potentially maternal and neonatal outcomes. While supine/lithotomy positions are common in many hospitals, evidence suggests upright positions (including all-fours) may shorten the second stage, reduce assisted deliveries, and improve maternal comfort. Childbirth is a significant physiological process, and the position a woman adopts during labor and delivery can have a profound effect on both maternal and neonatal outcomes. However, high-quality randomized evidence in the Nigerian setting (regional care practices, staffing, and cultural preferences) is limited. This randomized trial will provide locally relevant evidence to inform midwifery practice in the study region. The aim of the study is to compare the maternal and neonatal outcomes of normal deliveries between women who adopt upright (All fours) birthing positions and those who use supine positions during second stage of labor. Objectives 1. To evaluate the duration of labor between nulliparous women who adopt upright positions and those who use supine positions during second stage. 2. To assess the level of maternal comfort and satisfaction during delivery in upright versus supine positions in Nulliparous women during second stage. 3. To compare the incidence of medical interventions (e.g., episiotomy, assisted delivery, and use of oxytocin) between women in upright and supine positions during labor. 4. To examine the neonatal outcomes, including Apgar scores and birth weight, associated with upright and supine birthing positions.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 23/03/2026 I was asked to provide more information • Pregnant women booked for delivery at the study site with singleton pregnancy, cephalic presentation, gestational age ≥ 37 and ≤ 41+6 weeks. • In active labour in the second stage (full dilatation with expulsive efforts) and clinically eligible for vaginal birth. • Age 18 years and above (or local legal adult age); able to give informed consent. • Pregnant women in second stage of labour • Nulliparous women • Singleton pregnancy • Cephalic presentation • Gestational age: 37–42 weeks • Age group: 18–45 years
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 30/03/2026 I was asked to check and include those appliicable • Pregnant women in second stage of labour • Nulliparous women • Singleton pregnancy • Cephalic presentation • Gestational age: 37–42 weeks • Age group: 18–45 years • Participants included primigravida and multigravida women between 37 and 41 weeks of gestation with low-risk pregnancies who met the following criteria: - Spontaneous onset of labour, induction, or augmentation - Fetus in cephalic presentation - Reassuring fetal heart rate - Adequate pelvis on clinical pelvimetry - Willingness to provide informed consent - Singleton pregnancy - No major medical or obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa) - No history of previous caesarean section - Maternal age 18–44 years
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 23/03/2026 more update on the note • Multiple pregnancy, non-cephalic presentation. • Known obstetric complications that mandate specific positioning or operative delivery (e.g., placenta praevia, cord prolapse). • Severe preeclampsia/eclampsia, active cardiac disease, or other maternal conditions where upright positioning is contraindicated. • Fetal distress at the time of randomization requiring immediate delivery. • Women who decline randomization • Multiple pregnancy, non-cephalic presentation. • Known obstetric complications that mandate specific positioning or operative delivery (e.g., placenta praevia, cord prolapse). • Severe preeclampsia/eclampsia, active cardiac disease, or other maternal conditions where upright positioning is contraindicated. • Fetal distress at the time of randomization requiring immediate delivery. • Women who decline randomization • Women below 18 years and above 45years.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 23/03/2026 Was asked to provide more information TRUE, Imo Specialist Hospital Ethics Committee, umuguma, Owerri, 460271, Nigeria, , 03 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38308_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2026 I was told to reupload the ethics permission Letter TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2026 I was told to reupload the ethics permission Letter TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2026 I was told to reupload the ethics permission Letter TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2026 I was told to reupload the ethics permission Letter TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf TRUE, Specialist Hospital Ethics Committee, umuguma, Owerri, 460281, Nigeria, , 19 Sep 2025, +2348037270181, imospecialisthospital@yahoo.com, 41031_38349_4737.pdf