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

Persistent Occiput Posterior Position During Labor Clinical Trial

— MSIMSFPOP  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02209090
• Other study ID #: PR(AMI)182/2012
• Status: Unknown status
• Phase: N/A
• First received: July 2, 2014
• Last updated: August 1, 2014
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Vanessa Bueno, Midwife
• Email: vanessabuenolopez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 56
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Persistent Occiput Posterior Position During Labor

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	uterine dynamics	assessed by frequency and intensity according to Monteviedo unit calculation	During labour
Other	first stage in minutes	timed in minutes, from 3cm with cervix shortened until complete diltation.	During labour
Other	second stage in minutes	timed from complete dilation to foetal head expulsion	The first two hours after delivery
Other	epidural anaesthesia	doses of epidural anaesthesia required, concentration and ml.	During labour
Other	episiotomy	whether performed or not to gain a major opening from the soft parts of the birth canal.	The first two hours after delivery
Other	tear	trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:	The first two hours after delivery
Other	reason to end labour earlier	cause 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	The first two hours after delivery
Other	maternal comfort during labour	MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish	The first two hours after delivery
Primary	Rotation	the 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.	During labour
Secondary	rotating to OA	length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention	During labour
Secondary	Delivery mode	eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous	The first two hours after delivery