The Maternal Birthing Positions Health And Social Care Essay

Easy birth study: A randomised controlled trial to assess the efficacy of non-lithotomy birth positions during labour on maternal and foetal outcomes.

NAME: Amwe Sunday Aku

STUDENT NUMBER: 201315454

DEGREE: Philosophy Doctor (PhD): EPIDEMIOLOGY

SUPERVISOR: Prof Joanne Taylor

CO-SUPERVISOR: Prof Justus Hofmeyr

Contents

Introduction:

1.1Background and prior research rationale:

Difficult births encountered in second stage of labour which is, from full dilatation of the cervix to the expulsion of the foetus, during vaginal deliveries are still occurring, the vaginal birth process result in 65.7% maternal pelvic floor dysfunctions as well as poor foetal outcomes (Kepenekci et al. 2011). In a study to assess the association between parity, mode of delivery and pelvic floor disorders by Lukacz ES, Lawrence JM, Contreras R, Nager CW and Luber KM (2006), they found 7% pelvic prolapse, 15% stress urinary incontinence, 13% overactive bladder, 25% anal incontinence and 37% had one or more of the pelvic floor disorders (Lukacz ES et al. 2006).

Attempts at minimizing pelvic floor dysfunctions and making vaginal births easier are is still on-going. A recent systematic review by Gupta, Hofmeyr and Shehmar (2012), concludes that adopting various positions during the second stage of labour to ease birth difficulties requires further high level studies due to various methodological reasons (Gupta, Hofmeyr & Shehmar 2012).

Part of the methodological reason among the twenty trials included in the systematic review was poor allocation concealment; seven trials did not clearly outline whether the concealment envelopes were opaque or not (Waldestrom 1991, Stewart, 1989, Johnson 1987, Helmisnski 1986, Turner, 1984, Liddell 1985 and Hillan, 1984). In three other trials, there was inadequate information to determine what concealment methods were used (Allabadia 1992, Humphery 1973, Marttila 1983). A form of quasi randomisation was described in seven other trials (Bhardwaj 1994, Chan 1963, Gardosi 1989a, Gardosi 1989b, Suwanakam 1988). Only three trials described adequate allocation concealment (Crowley 1991, deJong 1997, Gupta 1989).

Another methodological reason was the inconsistency in the timing of allocation of women into the intervention of the studies; women were randomly allocated either late in first stage or at full dilatation (11 trials). In eight other trials, randomisation took place on admission (8). While in one study, women were allocated as early as 30 weeks and asked to attend special classes (Gupta 1989).

Other challenge with previous trials that did not conform to the consort statement on conducting randomised controlled trial as the sample size calculations were not reported in most of the trials included in the systematic review (Schulz et al. 2010).

Another challenge with the trials was the outcome measures of the trials reported. In some of the trials, analysis of the outcome did not adhere to the allotted randomised groups (Waldenstrom 1991; Crowley, 1991Liddell, 1985; Johnstone, 1987; Turner, 1986).

This study investigates the rationale of adapting non-lithotomy position in second stage of labour towards easy birth for both mother and her baby

1.2Rationale

Maternal birthing positions

The rationale of the non-lithotomy positions during second stage of labour is based on the theoretical framework that effects of gravity and less pressure on the great vessels of the abdomen will result in improved acid-based balance in the new-born (Ang 1969, Humphery 1974, Scott 1963; it results in stronger and more efficient uterine contractions (Caldeyro-Barcia 1960, Mendez-Bauer 1975); and adopting the kneeling position improves the alignment of the foetus during its passage through the birth canal as this position helps increase the total outlet diameter (Russel 1982, Gupta 1991, Lilford 1989).

The effect of gravity on the foetus assists in rotating the foetal head into suitable position during the second stage of labour. This is possible when the mother adopt certain positions during the second stage of labour for certain duration of time (Hofmeyr, Kulier 2005).

However, the systematic review suggests that in the interim, women should deliver in positions that are most comfortable for them until such a time when methodologically stringent trials are available to support the maternal positions adopted (Gupta, Hofmeyr & Shehmar 2012). This randomised, controlled trial will aim to address the shortcomings in methodology and conforming to the consort statement on conducting randomised controlled trials.

Trial Question

Aim

The aim of the randomised controlled trial is to determine if adopting non-lithotomy position by expectant nulliparous mother for comfortable duration of time during the second stage of labour would result in an easy birth within thirty minutes with reduction of maternal pelvic floor dysfunctions and improved maternal and foetal outcomes.

Primary objective

Determine the duration of second stage of labour

Secondary Objectives

Mode of infant delivery

Birth canal injuries

Obstetrics haemorrhage

Overview of the trial

Hypothesis

Adopting non-lithotomy position during second stage of labour for as long as is convenient for the mother would reduce birth duration and minimize pelvic floor dysfunctions thus improving maternal and foetal outcomes

Study Design

The study is designed to be a multiple-arm, randomised and controlled trial. The trial will compare efficacy of two non-lithotomy positions in second stage of labour against standard care of second stage of labour in reducing birth duration and minimizing pelvic floor dysfunctions.

The randomised trial is going to involve two delivery wards in two hospitals of the East London Hospital Complex, namely Cecilia Makiwane Hospital located at Mdantsane and Frere Hospital in the city centre of East London. Available data indicates that monthly delivery at both delivery wards stand at 300 and 500 deliveries respectively.

Participating women who give written informed consent would be allocated into one of the three groups; upright posture during second stage of labour (UP), upright posture with gentle fundal pressure (GFP) and standard care (SE).

Trial population

Trial site and study participants

The trial site would be the delivery wards of two East London hospital complexes. They are Cecilia Makiwane Hospital which conducts 300 deliveries in one month. The second delivery ward is in Frere Hospital which conducts 500 deliveries monthly. Participating women would be all consenting nulliparous pregnant women who are admitted into the labour wards. They would be randomised into any of the three arms when they are confirmed to be in second stage of labour and ready to start bearing down. (FIGO 2012).

Inclusion criteria

All consenting nulliparous pregnant women in second stage of labour, vertex presentation, with no contraindication for vaginal delivery

Exclusion criteria

Medical, surgical or obstetrics complications; in this category will include epilepsy, hypertension, jaundice in pregnancy, malaria, heart disease, cephalo-pelvic disproportion, antepartum haemorrhage, severe anaemia, rhesus negative mother, premature labour, unbooked mother,

Method of recruitment

Information about the study and invitation to participate would be provided to women attending antenatal clinics within the catchment area of the reference hospitals, these are East London and its environs for Frere Hospital as well as Mdantsane and its environs for Cecilia Makiwane Hospital.

At the delivery wards of the hospitals, nulliparous pregnant women who present in labour would be approached and reminded about the study and full information on the study provided by field workers stationed at the labour wards. Potential participants are then selected and written informed consent obtained.

Allocation of interventions

Randomisation and stratification

Randomization in a controlled trial aims to ensure balance between the intervention groups of prognostic factors, both known and unknown which may influence the outcome of the trial. In this study, randomization ensures reduction in selection bias and predictability of treatment allocation by trial participants. For this study, single allocation sequence into the intervention arms would be based on simple randomization. The sequence would be generated using a simple random table and kept in an opaque envelope.

When potential participants are admitted into the labour ward, field workers would approach them and remind them of the study. Those who give written informed consent would be subsequently randomised during the active phase of labour by the trial clinician or other trained field workers involved in the trial.

Allocation concealment

During recruitment, clients would be counselled that they could be allocated to any of the three study arm based on the simple randomization sequence as contained in the sealed opaque envelope which would only be opened during her second stage of labour.

The Interventions

General description

Having obtained written informed consent from the mother, and have met the inclusion criteria. The attending midwife would allocate the mothers into any of the three arms of the intervention based on the simple randomised sequence of allocation as contained in the opaque envelopes located with the study staff in the delivery ward. The envelopes are only opened when it is established that the woman has entered into the second stage of labour. At this stage, it is pertinent to note that, she may or may not have the urge to bear down; there could be presence or absence of the progressive parting of and appearance of the presenting part at the introituses.

Upright position in second stage labour (KP)

The expectant mother, having attained second stage of labour, would be placed by the researcher into a kneeling or crouch position with her hips well flexed at the hip joint. The duration she remains in the position is noted. The mother is permitted to remain in this position as long as it convenient for her or until expulsion of the baby. The duration of the kneeling position and that of subsequent convenient position till delivery is noted.

Semi-recumbent position at 45 degrees (GFP)

When study participant is randomised into this intervention, she is placed in the semi-recumbent position with the delivery bed inclined at 45 degrees to the horizontal. The time she adopts this position is noted and the expectant mother is allowed to remain in this position for the duration that is most convenient for her. If she is uncomfortable, she is permitted to adopt any position which is most convenient for her till delivery of the baby. Similarly, the duration from adopting the GFP to delivery is noted. When expectant mother has the urge to bear down, the researcher would apply gentle sustained fundal pressure during the time the mother has the urge to bear down and having uterine contractions. The gentle fundal pressure is continued for the duration that the uterine contractions are observed and the urge to bear down is present until the expulsion of the foetus. The duration of application of application of fundal pressure is noted and recorded.

Standard care (SC)

Intending mothers in labour, who are randomised to receive the standard care, would be allowed to progress into the second stage of labour. They would receive the standard care as offered in the delivery wards of either Cecilia Makiwane Hospital or Frere Hospital delivery wards. The duration from active phase of labour, to full dilatation of the cervix, and from full dilatation of the cervix to the expulsion of the foetus would be noted and documented.

Post recruitment retention strategy

Participant retention

Prior sensitization campaigns targeting both staff and pregnant mothers would be done. The sensitization would involve regular visits to the catchment or feeder antenatal clinics where most of the women who deliver in the delivery wards of the two hospitals receive antenatal care.

Staff involved in the delivery wards of the respective hospitals would be given initial training on the study, and regular updates on the progress of the study to aid client retention and adherence to ICH-GCP as well as protocol of the study. This would ensure correct and complete data collection without deviation from the study protocol.

The researcher would avail himself to all stake holders within the health system that may need clarification on any aspect of the study. He would then respond accordingly.

Trial outcomes

Primary outcomes

The primary outcome measures are:

1. There is no spontaneous delivery after 30 minutes from randomisation.

2. The presence of cord arterial blood pH of <7.2 indicating some form of foetal distress.

3. Maternal pelvic floor trauma, for this study would be defined as the presence of perianal trauma involving second or third degree lacerations, episiotomies, cervical lacerations and uterine ruptures.

Secondary outcomes

Maternal outcome:

mode of delivery

pain threshold

use of analgesics immediate period after delivery

stress urinary incontinence

anal faecal incontinence

bladder insufficiency

pelvic prolapse,

maternal blood pressure and

obstetrics haemorrhage

Foetal outcomes:

persistent occiput-posterior at birth

Abnormal foetal heart rates.

Neonatal outcomes:

Neonatal condition as defined by the APGAR score in 10 minutes

stay in special care baby unit

.Perinatal or early neonatal death.

Outcome assessment

The primary outcome assessment is going to be estimated from the time of randomisation in second stage of labour to the delivery of the foetus. The general assumption is that from the full dilatation of the cervix to delivery of the foetus should not exceed thirty minutes (30mins).

Maternal outcome

The maternal outcome measures would be as follows:

Delivery mode:

The delivery could be spontaneous vagina delivery, assisted vaginal delivery (forceps or ventouse) or emergency lower segment caesarean section.

Pelvic floor dysfunction:

The dysfunction would be assessed using the standard pelvic floor disorder network questionnaire attached as annexure III. The process will require telephonic interview with the mother six weeks after delivery. The contact details of the mother will be obtained and her phone will be credited with 10 Rand worth of airtime to allow for ease of communication.

Maternal blood pressure:

Maternal blood pressure would be assessed during the phase I, phase II and phase III of labour. Maternal systolic blood pressure between 100 and 139 mmHg while a diastolic between 60 and 99 mmHg would be considered within acceptable normal blood pressure.

Maternal blood loss:

Postpartum blood loss would be estimated by placing a light weight plastic drape under the perineum to collect any blood expelled by the mother for duration of thirty (30) minutes after delivery. The drape is then placed in a standardised plastic bucket of known weight and the weight of the drape with collected blood would provide an estimate of the blood loss.

Foetal outcome

Persistent occiput-posterior:

This is determined by the position of the foetus at delivery.

Abnormal foetal heart rates:

This is obtained as recordings on the cardiotocography readings.

Neonatal outcome

Neonatal APGAR score:

The neonate APGAR score at 10 minutes will determine the severity of infant depression which could have long term sequelae on the neonate. Generally, a score of less than five (5) is considered a poor APGAR score.

Special care baby unit:

Any neonate admitted into the special baby care unit indicates some form of severity and would be noted. Any perinatal or early death would be noted

Safety monitoring and adverse events

Safety monitoring

Adverse event reporting requirements

Data Collection and management

Data collection

The International Conference on Harmonization of Good Clinical Practice guidelines and principles would guide data collection process for this study. For this study, the researcher is a trained ICH-GCP researcher and the study would ensure that all members of the team be GCP certified.

Data management system

The generated copies of the paper CRFs would be securely kept in locked cabinets with restricted access to the researcher and only authorised members of the research. Regular standardization and validation of data captured would be done at regular intervals to ensure no discrepancy in data collected.

Data entry

The data would be collected on paper Case Report Forms (CRFs) and later transcribed into EpiData version 3.1. The researcher would ensure that the transcribed data would be validated using the special tool contained in the software that ensures correct data capture. The design, collection, transcription of the CRFs, storage and transportation to a central point would be based on the ICH-GCP principles.

Quality control

The researcher will ensure standardization and training of other personnel that would assist with the trial between the two delivery wards. The training would involve staff in the delivery wards of both facilities involved in the study to provide them adequate orientation and interventions of the study which has been observed as one of the limitations of previous studies conducted (ref).

Progress reports

Regular progress reports quarterly would be submitted to the ethics committee. Should there be any adverse event occurring during the course of the study, the event would be reported immediately to the hospital ethics committee, provincial department health ethics as well as the ethics committee of the university of Fort Hare.

Final reports

Analysis strategies

Draft data analysis plan is included in the protocol. The primary outcome analysis is by intention to treat basis for randomised controlled trials. The comparisons would be between the three arms, upright position, upright position with gentle pressure and standard of care.

Dummy tables

The initial plan of analysis table is attached as Appendix 2 and has been proposed before the initial recruitment of study participants.

Statistical analysis

Baseline data would be compared to ensure effectiveness of the randomisation process. Outcome variable will be compared as relative risks for categorical variables and mean differences for continuous variables with 95% confidence intervals for both.

Sample size

Sample size justification

Compliance and missing data

Ethical aspects

Participant consent

Trial management

Registering the trial

Trial management

Local coordination

Research governance and good clinical practice

Reporting, Dissemination and Notification of results

Publication policy

Disseminating the results

References

APPENDIX 2

Intervention

CMH

FH

Total

Upright position

Gentle fundal pressure

Standard care

Total

Table Recruitment rates by delivery wards

Upright position

Gentle fundal pressure

Standard care

Total

N

%

N

%

N

%

Age (mean, SD

Education level

Gestational age

Total

Table 2 Characteristics of women at trial

Upright position

Gentle fundal pressure

Standard care

Total

Mean

SD

Interquartile Range

Compliance index

Table 3 Compliance with allocated treatment duration

Upright position (UP)

Gentle Fundal Pressure (GFP)

Standard care (SC)

Relative Risk (95% confidence interval)

Total

N

%

N

%

N

%

UP vs SC

GFP vs SC

UP Vs GFP

Primary outcome

Delivery <30mins

Cord blood pH<7.2

Birth canal injury

Secondary outcome

mode of delivery

pain threshold

use of analgesics immediate period after delivery

stress urinary incontinent

anal faecal incontinence

bladder insufficiency

pelvic prolapse

maternal blood pressure and obstetrics haemorrhage

Table 4 Trial outcomes: Mother

Upright position

Gentle fundal pressure

Standard care

Total

N

%

N

%

N

%

Foetal outcome

persistent occiput-posterior at birth

Abnormal foetal heart rate

Neonatal outcome

Neonatal condition as defined by the APGAR score in 10 minutes

stay in special care baby unit

Perinatal or early neonatal death

UNIVERSITY OF FORT HARE

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