Clinical trial NCT02209090: Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions
Official title: Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Occiput Posterior Position During Labor
Keywords: occiput-posterior
occipitoposterior
labour
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2014-08-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

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.

Detailed description: Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

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

Eligibility criteria: Inclusion Criteria:

* adult pregnant women (\>18 years of age)
* 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:

* multiple gestations
* 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

Primary outcomes:
measure: Rotation
timeFrame: During labour
Secondary outcomes:
measure: rotating to OA
timeFrame: During labour
measure: Delivery mode
timeFrame: The first two hours after delivery
Other outcomes:
measure: uterine dynamics
timeFrame: During labour
measure: first stage in minutes
timeFrame: During labour
measure: second stage in minutes
timeFrame: The first two hours after delivery
measure: epidural anaesthesia
timeFrame: During labour
measure: episiotomy
timeFrame: The first two hours after delivery
measure: tear
timeFrame: The first two hours after delivery
measure: reason to end labour earlier
timeFrame: The first two hours after delivery
measure: maternal comfort during labour
timeFrame: The first two hours after delivery
Locations:
city: Barcelona
country: Spain
facility: Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),
Study officials:
affiliation: HUValldebronRI
name: Vanessa Bueno, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.