Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions
NCT ID: NCT02209090
Last Updated: 2014-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2014-03-31
2016-06-30
Brief Summary
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Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.
The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.
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Detailed Description
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Background: There is a theoretical basis for the possible effects of maternal positions on foetal positions. Despite all the studies published in recent years, conclusive trials providing significant scientific evidence are lacking.
Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.
The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.
Discussion: If the modified maternal Sims position proved to correct persistent foetal occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for both mother and foetus, maternal and foetal morbidity problem would be reduced
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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maternal modified sims position
Women in this group will adopt the modified Sims position, lying on the side of the foetal back.
This position is maintained for the greater part of labour, at least 40 minutes, every hour. The mother can use other positions during resting time of no more than 20 minutes each hour, but never use a lateral position against the side of the foetal back.
maternal modified sims position
Maternal Modified Sims position during at least 40 minutes for each 60 minutes
maternal free positions
Women can adopt the position they wish and which is most comfortable, except for lateral positions which can only be used for a maximum of 20 minutes each hour to avoid confounding factors.
maternal free positions
At least 40 minutes each hour during labour
Interventions
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maternal modified sims position
Maternal Modified Sims position during at least 40 minutes for each 60 minutes
maternal free positions
At least 40 minutes each hour during labour
Eligibility Criteria
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Inclusion Criteria
* persistent posterior foetal position diagnosed during labour through two vaginal examinations two hours apart.
* at-term gestations (37 to 42 weeks)
* women in labour with epidural anaesthesia
Exclusion Criteria
* previous severe foetal malformation diagnosed
* macrosomic foetus diagnosed by ultrasound in the 3rd trimester (\> percentile 95), or IUGR (\< percentile 10)
* women with contraindicated vaginal delivery owing to previous vaginal surgeries
* women with severe heart diseases
* diabetic pregnant women (types I, II and gestational)
* hypertension problems during labour
* myopathies
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Barcelona
OTHER
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Vanessa Bueno, PhDcandidate
Role: PRINCIPAL_INVESTIGATOR
HUValldebronRI
Locations
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Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Bueno-Lopez V, Fuentelsaz-Gallego C, Casellas-Caro M, Falgueras-Serrano AM, Crespo-Berros S, Silvano-Cocinero AM, Alcaine-Guisado C, Zamoro Fuentes M, Carreras E, Terre-Rull C. Efficiency of the modified Sims maternal position in the rotation of persistent occiput posterior position during labor: A randomized clinical trial. Birth. 2018 Dec;45(4):385-392. doi: 10.1111/birt.12347. Epub 2018 Mar 14.
Other Identifiers
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PR(AMI)182/2012
Identifier Type: -
Identifier Source: org_study_id
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