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Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions

Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209090
Acronym
MSIMSFPOP
Enrollment
56
Registered
2014-08-05
Start date
2014-03-31
Completion date
2016-06-30
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Occiput Posterior Position During Labor

Keywords

occiput-posterior, occipitoposterior, labour

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

Interventions

PROCEDUREmaternal modified sims position

Maternal Modified Sims position during at least 40 minutes for each 60 minutes

PROCEDUREmaternal free positions

At least 40 minutes each hour during labour

Sponsors

University of Barcelona
CollaboratorOTHER
Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
RotationDuring labourthe foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.

Secondary

MeasureTime frameDescription
rotating to OADuring labourlength of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention
Delivery modeThe first two hours after deliveryeutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous

Other

MeasureTime frameDescription
epidural anaesthesiaDuring labourdoses of epidural anaesthesia required, concentration and ml.
episiotomyThe first two hours after deliverywhether performed or not to gain a major opening from the soft parts of the birth canal.
uterine dynamicsDuring labourassessed by frequency and intensity according to Monteviedo unit calculation
reason to end labour earlierThe first two hours after deliverycause that occurs on ending labour before it concludes spontaneously. Reasons may be foetal: risk of loss of foetal wellbeing, or maternal: pelvic foetal disproportion or stopped labour
maternal comfort during labourThe first two hours after deliveryMACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish
tearThe first two hours after deliverytrauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:
first stage in minutesDuring labourtimed in minutes, from 3cm with cervix shortened until complete diltation.
second stage in minutesThe first two hours after deliverytimed from complete dilation to foetal head expulsion

Countries

Spain

Contacts

Primary ContactVanessa Bueno, Midwife
vanessabuenolopez@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026