Labor; Prolonged, Second StageNCT06928038
Maternal Position's Effect on Labor Progression in Occiput Posterior Deliveries
A study testing Positioned group in people with Labor; Prolonged, Second Stage and Delivery Problem, run by Biruni University.
Trial summary
This is a randomized controlled experimental study to determine the effect of maternal position on the progression of labour in deliveries in which the foetus is in the occiput posterior position. The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor; Prolonged, Second Stage, Delivery Problem
- What is being tested?
- Positioned group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 30 Apr 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gravidas aged 18 years or older
- Between 36 and 42 weeks of gestation
- Willing to participate in the study
- Expected to deliver vaginally
- Not classified as high-risk
- No obstetric or medical complications during labor
Show all 10Show fewer
- Single, healthy fetus in one of the following positions: occiput posterior, left occiput posterior, right occiput posterior, left occiput transverse, or right occiput transverse (confirmed via ultrasonography)
- Cervical dilation of at least 2-3 cm
- Estimated fetal weight between 2500 g and 3999 g
- No major congenital anomalies
Who cannot join
- Inability to understand Turkish
About this study
Official title: The Effect of Maternal Position on Labour Progression in Deliveries With the Foetus in the Occiput Posterior Position
This is a randomized controlled experimental study to determine the effect of maternal position on the progression of labour in deliveries in which the foetus is in the occiput posterior position.
The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.
Read the detailed description
This is a randomized controlled experimental study. The research was carried out in a private hospital in Istanbul. The population of the study covered gravidas who were admitted to the hospital for delivery with the foetus in the occiput posterior position in labour. The sample of the study included 148 volunteering gravidas, who were divided into intervention and control groups.
Research Hypotheses:
H1: In deliveries where the foetus is in the occiput posterior position, the positions given to the mother help the foetus to rotate to the occiput anterior position.
H2: Positions given to the mother in the occiput posterior position do not affect the Apgar score.
H3: In deliveries where the foetus is in the occiput posterior position, the positions given to the mother reduce the rate of interventional delivery.
Implementation :
After the occiput posterior position was established by ultrasonography, the gravidas included in the study were randomized into 2 groups as intervention and control groups. The intervention group was given the following positions during labour:
- The gravida is given a side-lying position on the side of the occiput for 20 minutes. She is laid with the lower leg bent and the upper leg extended.
- Then the prostrate position is given for 15 minutes (This position is where the pregnant women kneels while lowering her forehead to touch the bed or floor).
- After this position, they are allowed to rest for 10 minutes by leaning towards the head of the bed.
- Then, they are given a side-lying position again on the side of the occiput for 20 minutes.
After 1 hour, the gravida was placed in a side lying position on the side of the occiput. Digital vaginal examination was repeated at 2 hour intervals. If the foetus has rotated to the occiput anterior position, the women was released (could walk, stand, allowed to do as she pleased). If the occiput posterior continued but the descent of the head was progressing, she was tilted to the side of the occiput on the delivery table after the dilatation is completed and instructed to push (keeping the upper leg up). At the time of coronation, she was laid on her back and delivered. If there was no head descent or rotation according to the digital vaginal examination finding, time was allowed for dilatation to reach 7-8 cm in the primiparae. Caeserean section (C/S) was scheduled if there was no change. If the posh was not open in multiparous patients and the head was at -3 -2, amniotomy was performed and time was allowed until dilatation was complete. However, C/S was planned if digital vaginal examination performed with an interval of 2 hours did not indicate progress.
The control group was followed up in the routine delivery room, and no positioning was done.
- Conditions
- Labor; Prolonged, Second Stage, Delivery Problem
- Being tested
- Positioned group
- Keywords
- Foetal malposition, Occiput posterior stance, Delivery positions
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioned groupBehavioural
applied a side-lying position (20 minutes) on the occiput side and a prostrate position (15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The positioned group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. Receives: Behavioral: Positioned group |
| Control group | No intervention | The control group was followed up in the routine delivery room, and no positioning was done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth type of the baby
cesarean section, spontaneously deliver
Measured: from labor to the end of the delivery
Head position
right - left occiput posterior; right - left occiput transverse; right - left occiput anterior
Measured: From labor to the expulsion stage
Secondary outcomes (1)
duration of expulsion phase
The time from completion of dilatation to birth of the baby
Measured: duration of expulsion phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Feb 2015
- Primary completion30 Dec 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor; Prolonged, Second StageStudies 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
- Single group
- Model description
- The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezihe KIZILKAYA BEJI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928038
- Sponsor's protocol ID
- 10840098-241
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Position on Labour Progression in Deliveries With the Foetus in the Occiput Posterior Position
- ClinicalTrials.gov ID
- NCT06928038
- Acronym / sponsor ID
- 10840098-241
- Conditions
- Labor; Prolonged, Second Stage, Delivery Problem
- Keywords
- Foetal malposition, Occiput posterior stance, Delivery positions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 15 Apr 2025 (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.
This is a randomized controlled experimental study to determine the effect of maternal position on the progression of labour in deliveries in which the foetus is in the occiput posterior position.
The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.
Detailed description
This is a randomized controlled experimental study. The research was carried out in a private hospital in Istanbul. The population of the study covered gravidas who were admitted to the hospital for delivery with the foetus in the occiput posterior position in labour. The sample of the study included 148 volunteering gravidas, who were divided into intervention and control groups.
Research Hypotheses:
H1: In deliveries where the foetus is in the occiput posterior position, the positions given to the mother help the foetus to rotate to the occiput anterior position.
H2: Positions given to the mother in the occiput posterior position do not affect the Apgar score.
H3: In deliveries where the foetus is in the occiput posterior position, the positions given to the mother reduce the rate of interventional delivery.
Implementation :
After the occiput posterior position was established by ultrasonography, the gravidas included in the study were randomized into 2 groups as intervention and control groups. The intervention group was given the following positions during labour:
- The gravida is given a side-lying position on the side of the occiput for 20 minutes. She is laid with the lower leg bent and the upper leg extended.
- Then the prostrate position is given for 15 minutes (This position is where the pregnant women kneels while lowering her forehead to touch the bed or floor).
- After this position, they are allowed to rest for 10 minutes by leaning towards the head of the bed.
- Then, they are given a side-lying position again on the side of the occiput for 20 minutes.
After 1 hour, the gravida was placed in a side lying position on the side of the occiput. Digital vaginal examination was repeated at 2 hour intervals. If the foetus has rotated to the occiput anterior position, the women was released (could walk, stand, allowed to do as she pleased). If the occiput posterior continued but the descent of the head was progressing, she was tilted to the side of the occiput on the delivery table after the dilatation is completed and instructed to push (keeping the upper leg up). At the time of coronation, she was laid on her back and delivered. If there was no head descent or rotation according to the digital vaginal examination finding, time was allowed for dilatation to reach 7-8 cm in the primiparae. Caeserean section (C/S) was scheduled if there was no change. If the posh was not open in multiparous patients and the head was at -3 -2, amniotomy was performed and time was allowed until dilatation was complete. However, C/S was planned if digital vaginal examination performed with an interval of 2 hours did not indicate progress.
The control group was followed up in the routine delivery room, and no positioning was done.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Positioned groupThe positioned group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. |
| Control group | No intervention | –The control group was followed up in the routine delivery room, and no positioning was done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Gravidas aged 18 years or older
- Between 36 and 42 weeks of gestation
- Willing to participate in the study
- Expected to deliver vaginally
- Not classified as high-risk
Key exclusion criteria (1 listed)
- Inability to understand Turkish
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 |
|---|---|---|
| Positioned groupapplied a side-lying position (20 minutes) on the occiput side and a prostrate position (15 minutes). | Behavioural | Intervention group |
Primary outcome
birth type of the baby
Time frame: from labor to the end of the delivery
cesarean section, spontaneously deliver
Head position
Time frame: From labor to the expulsion stage
right - left occiput posterior; right - left occiput transverse; right - left occiput anterior
1 secondary outcome
duration of expulsion phase
Time frame: duration of expulsion phase
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 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Positioned group in people with Labor; Prolonged, Second Stage and Delivery Problem, run by Biruni University.
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 10 inclusion and 1 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
birth type of the baby (time frame: from labor to the end of the delivery). The study lists 2 primary outcomes in all. 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 17 Apr 2025.