Fetal Manual RotationRMOSNCT03009435
RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)
A study testing prophylactic manual rotation in people with Fetal Manual Rotation, run by University Hospital, Angers.
Trial summary
Introduction: The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. 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
- Fetal Manual Rotation
- What is being tested?
- prophylactic manual rotation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- 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
- Inclusion Criteria:
- age ≥ 18 years
- singleton pregnancy -≥37 weeks of gestation
- planned vaginal birth
- cephalic presentation
- occiput posterior position confirmed by ultrasound at full dilatation
- Exclusion Criteria:
- withdrawal of consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate
Introduction:
The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.
Read more
Methods:
Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.
The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.
Analysis will be by intention-to-treat averaging a 24-month period.
- Conditions
- Fetal Manual Rotation
- Being tested
- prophylactic manual rotation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic manual rotationOther
| Study group | Role | What they receive |
|---|---|---|
| prophylactic manual rotation | Experimental | Only obstetricians will participate in the study. Manual rotation is performed at full dilatation.The technique employed will be at the discretion of the operator performing the procedure :
* Tarnier and Chantreuil technique
* or SOGC technique Receives: Other: prophylactic manual rotation |
| expectative management | No intervention | Expectative management . No manual rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of spontaneous vaginal delivery
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Manual RotationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009435
- Sponsor's protocol ID
- 2016-A01456-45
- Acronym
- RMOS
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
Publications
Verhaeghe C, Corroenne R, Spiers A, Descamps P, Gascoin G, Bouet PE, Parot-Schinkel E, Legendre G. Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.
PubMed 33957650Verhaeghe C, Parot-Schinkel E, Bouet PE, Madzou S, Biquard F, Gillard P, Descamps P, Legendre G. The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS). Trials. 2018 Feb 14;19(1):109. doi: 10.1186/s13063-018-2497-7.
PubMed 29444695
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate
- ClinicalTrials.gov ID
- NCT03009435
- Acronym / sponsor ID
- RMOS / 2016-A01456-45
- Conditions
- Fetal Manual Rotation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- First posted
- 4 Jan 2017 (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.
Introduction:
The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.
Methods:
Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.
The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.
Analysis will be by intention-to-treat averaging a 24-month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic manual rotation | Experimental | Other: prophylactic manual rotationOnly obstetricians will participate in the study. Manual rotation is performed at full dilatation.The technique employed will be at the discretion of the operator performing the procedure : * Tarnier and Chantreuil technique * or SOGC technique |
| expectative management | No intervention | –Expectative management . No manual rotation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| prophylactic manual rotation | Other | prophylactic manual rotation |
Primary outcome
Percentage of spontaneous vaginal delivery
Time frame: At the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 33957650Verhaeghe C, Corroenne R, Spiers A, Descamps P, Gascoin G, Bouet PE, Parot-Schinkel E, Legendre G. Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.
- Derived from this study: PubMed 29444695Verhaeghe C, Parot-Schinkel E, Bouet PE, Madzou S, Biquard F, Gillard P, Descamps P, Legendre G. The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS). Trials. 2018 Feb 14;19(1):109. doi: 10.1186/s13063-018-2497-7.
Related trials for Fetal Manual Rotation
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Trial of Ultrasound-guided Rotation for Normalizing Head Position
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Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation
Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice
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.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic manual rotation in people with Fetal Manual Rotation, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Verhaeghe (+3364184459, verhaeghe.caroline@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of spontaneous vaginal delivery (time frame: At the time of 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 NCT03009435, which also lists 2 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 4 Jan 2017.