Does postural management promote spontaneous cephalic version of breech presentation in the third trimester of pregnancy?
A randomised control trial proposal
- INTRODUCTION AND BACKGROUND
Breech presentation involves a longitudinal lie of the fetus with the buttocks in the lower pole of the maternal uterus. The incidence of breech presentation in the UK is approximately from 4 to 5% at term, although it is much higher earlier in pregnancy (Shennan and Brewley, 2001; Hofmeyr et al., 2015; Hoffmann et al., 2016). The evidence indicates that breech presentation at any point in the third trimester is associated with an increased likelihood that the baby will remain breech at birth (Tadmor et al., 1994).
The risk factors which may predispose to a breech presentation are numerous, such as previous breech delivery, multiple pregnancy, premature labour, placenta praevia, uterine or fetus abnormalities, abnormal amniotic fluid volume, (Collins et al., 2007; Ulander et al., 2004), old maternal age, nulliparity, low neonatal weight and neonatal female gender (Fruscalzo et al., 2014).
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Maternal posture is intended to reduce the incidence of breech presentation at birth and its concomitant risks in pregnancy (Chenia and Crowther, 1987; Clay et al., 1993; Hofmeyr and Kulier, 2012). Breech delivery is associated with a higher perinatal morbidity and mortality than cephalic birth, due principally to prematurity, congenital malformations, birth asphyxia or trauma (Cheng & Hannah, 1993) and cerebral palsy (Morken et al., 2010, O’Callaghan & MacLennan 2013).
Nowadays, when women ask for alternatives to turn their babies to a cephalic presentation, they are routinely recommended External Cephalic Version (ECV) or a planned cesarean section (CS). The Term Breech Trial (TBT) in 2000 suggested a policy of planned CS for the singleton fetus in the breech presentation at term to reduce the associated perinatal problems. However, the findings of the TBT are controversial given the many concerns about the methodology and analysis (Hunter, 2014). The PREMODA study demonstrated that vaginal birth remains a safe option for women with a singleton breech presentation at term when certain criteria are met (Goffinet el at., 2006).
NICE (2008) and RCOG (2006) guidelines state that external cephalic version should be offered to women with an uncomplicated singleton breech presentation from 36 weeks gestation. Although ECV is recommended, only 30-50% of women with breech presentation in the UK currently undergo ECV (Hemelaar et al., 2015). Women should be advised that, with a trained operator, about 50% of ECV attempts will be successful (Hemelaar et al., 2015; RCOG, 2006). ECV is considered a safe procedure and it is rarely associated with complications. Nevertheless, a few case reports mention complications such as placental abruption, uterine rupture, fetomaternal haemorrhage and emergency caesarean section at the time of ECV (Shankar 2004, Collaris & Oei, 2004)
It has been witnessed an enormous growth in the use and request of complementary therapies in the general population in the last decade, particularly within the midwifery services, and this has created a consequential demand for complementary therapies to be available within the NHS (Ernst and White, 2000). Postural interventions for breech presentations are commonly recommended in practice. It is a non-invasive intervention and due to its simplicity and its query potential, it could be applied in different settings. This practice is based on tradition, anecdotal evidence and lay midwifery publications. However, research on postural management is a non-evidence based practice and research on this topic has been inconclusive (Hofmeyr & Kulier; 2012). This gap between practice and research evidence calls for further investigation by means of larger randomised control trials.
The two types of maternal posture found on the literacy are Knee-chest posture and Indian posture.
In knee-chest posture, the woman is positioned kneeling, leaning forward keeping hips elevated, and with head, arms, and chest on the floor or bed. Chenia and Crowther (1987) randomly assigned 76 pregnant women with singleton breech presenting fetuses at 37 weeks gestation or more to control or intervention groups. Spontaneous cephalic version occurred in 41% of the intervention group and 32.3% of the control group. Smith et al (1999) replicated the previous study protocol and added ECV to the research for both intervention and control groups (51 and 49 respectively) if the infants did not rotate to cephalic presentation after 1 week of maternal participation. The author reported that the postural intervention did not reduce breech presentations in their study.
Another postural method is ‘Indian posture’, where the woman is positioned lying supine with her head down, hips elevated on bolster pillows, and legs bent at the knees with feet on the floor or bed. Two trials tested for Indian Posture. Bung et al. (1987) conducted a small randomized trial of women with breech-presenting pregnancies between 30-35 weeks gestation. No statistical statements were made due to the low numbers of subjects (30 and 31 in the intervention and control group respectively), but the authors concluded that due to the low risk and good acceptance of the posture, it could be recommended. Another randomised trial carried out by Obwegeser et al., (1999) showed no significant difference among intervention and control group. One hundred and three subjects were recruited, but 3 were excluded for poor compliance. 50 women were in intervention and 50 in control group. The amount and timing of the interventions differed between the two trials.
A cochrane review conducted by Hofmeyr and Kulier (2012) reported all postural management trials enrolled too few participants to show whether there was a small or small-to-moderate difference in cephalic version by posture compared with spontaneous version. The independent variable, postural intervention, varied in each of the studies by the amount of time the posture was performed by the intervention group participants. It has not found any study which includes both postures.
Relaxation, the motion created by deep abdominal breathing, hip elevation, gravity, or the amount of space in the uterus or maternal abdomen were all possible explanatory factors for version by postural management (Founds, 2006). None of the studies reported maternal or fetal problems related to the intervention
- RESEARCH HYPOTHESIS
The primary objective of this study is to assess whether a combination of Indian posture and Knee-chest posture increases the spontaneous cephalic version of breech-presenting infants confirmed by ultrasound scan at 33-35 weeks of gestation.
It will compare the rates of spontaneous cephalic version by parity, maternal age and ethnicity as they are factors that may confound the effect of maternal posture on spontaneous version, as identified by previous researchers in limitations of their RCTs (Chenia and Crowther, 1987; Bung et al., 1987).
H1: Women in the postural management group will experience a higher rate of spontaneous cephalic version than those on the control group at 36 weeks of gestation.
Ho: There will not be significant differences of spontaneous cephalic version rate among women in the intervention group and the control group at 36 weeks of gestation.
The most appropriate design to achieve accurate and reliable results is a Randomised Control Trial (RCTs).
The selection of a Randomised Control Trial design is made by taking into consideration that RCTs use an experimental design where the participants have been randomly allocated to a control or experimental group. Although RCTs are costly and time consuming, they are considered to be the most appropriate research method to investigate the effectiveness of a treatment or intervention. This is because they examine the likelihood of a cause-effect relationship between variables thought the use of statistical calculations (Burns and Grove, 2009).
Assigning participants at random reduces the risk of bias and increases the probability that any differences between both groups can be attributed to the intervention (maternal posture). Randomisation also ensures that additional factors, called confounding variables, that may also influence the results are evenly distributed between the two groups. Random allocation will be performed by using opaque sealed envelopes so that it is not possible to anticipate the allocation until the envelope has been opened.
To reduce bias as much as possible, participants in the study would not know whether they are in the intervention or the control. This is known as single blinding.
– Study area
The study will be conducted in Homerton University Hospital, which is based in Hackney area, London. Homerton University Hospital provide care for more than 6.000 pregnant women each year (Homerton NHS Trust, 2014).
This Trust has a maternity department with high rates of antenatal care appointments at the hospital and local community services; and it has an ultra-sound scan department based within the hospital.
– Study population
Women aged 18 or more with a singleton pregnancy from 33 to 35 weeks gestation with a confirmed fetal breech presentation via ultrasound scan.
The rationale for intervening from 33 to 35 weeks gestation is to allow time for ECV if maternal posture did not promote spontaneous cephalic version.
Women with the following conditions or pregnancy complications will be excluded:
– Certain types of heart and lung diseases
– Multiple pregnancy
– Contraindications to vaginal delivery
– Placenta previa after 26 weeks of pregnancy
– Preeclampsia or pregnancy-induced high blood pressure
– Persistent 2nd / 3rd trimester bleeding
– Intrauterine growth restriction
– Cervical insufficiency or cerclage
– Preterm labour, ruptured membranes or threatened miscarriage during this pregnancy
This decision has been made according to the contraindications to exercise in pregnancy by the American College of Obstetricians and Gynaecologists (2002).
Sample size calculation
The sample to be studied will be appropriate to the hypothesis being tested so that any results are appropriately generalizable. Quantitative researchers are generally advised to use the largest sample possible since it is more reliable and representative.Validity increases with sample size (Rees, 2012). The study will recruit sufficient women to allow it to have a high probability of detecting a clinically important difference between interventions if a difference truly exists.
The statistical procedure of power analysis can be used to estimate the total size of the sample needed, given an anticipated difference in the results between the two groups (Procter et al., 2010). By enrolling too few subjects, a study may not have enough statistical power to detect a difference (type II error). Enrolling too many patients can be unnecessarily costly or time-consuming.
Power analysis will also help to avoid a type I error, finding a difference when a difference does not exist, a false positive; or a type II error, not detecting a difference when one exists, a false negative.
Before the study is commenced, midwives, obstetricians and ultrasound technicians from the maternity ultrasound department in Homerton University Hospital will be informed about the study via email.
A pilot study will be carried out to familiarise data collectors with the procedure and the data collection process.
Method of recruitment
Midwives from Antenatal Clinic (ANC) and community practices within Homerton University Hospital will refer women to the scan department if any concern of a breech presentation during the 34 weeks routine antenatal appointment.
Participants who meet the inclusion criteria will be recruited following confirmation of breech presentation via ultrasound scan in the hospital-based ultrasound department.
General information about the study will be displayed through an information sheet by ultrasound technicians who are familiar with the study. Participants interested on the study will be referred on the same day to a study recruiter who will see them personally. If unable to do so on that day, the participant will be rescheduled within the week to see a study recruiter. Participants will read and discussed the consent form only with a recruiter and complete the data collection sheet. APPENDIX A.
Procedure and data collection
Participants will be randomly allocated whether in the intervention group (Group 1) or in the control group (Group 2) by using opaque sealed envelopes.
Women in the intervention group will be expected to assume an Indian posture and Knee-chest posture every day for 20 minutes twice a day.
Women in the control group will be encouraged to continue with their normal activities.
Instructions sheet for each activity and study booklet will be given and explained to each participant. APPENDIX B
Participants will be given a phone number to reach the researcher in case of questions or problems. The researcher will telephone each participant on the first, third and fifth days of study participation. Phone follow-up through the week of study participation aimed to remind subjects of the study and to screen unforeseen problems needing referral to the researcher.
Each participant will be offered an ultrasound scan at 36 weeks of gestation to determine fetal presentation. If baby persists breech, participants should be referred to the consultant in ANC. ECV should be recommended from 36 weeks gestation as per NICE (2008) and Homerton Antenatal Guidelines (2011).
Fetal presentation will be recorded on the participant’s data collection sheet and this will be collected by a study researcher following the ultrasound scan at 36 weeks.
Participants will be advised to discontinue the activities and contact immediately the maternity service if they experience vaginal bleeding, membrane rupture, acute pain or reduced fetal movements.
Quantitative research is concerned with measuring a variable in a way that produces a numeric value. Statistics are an essential part of RCTs as they indicate the extent to which the intervention introduced by the researcher had an impact on the outcome. In data analysis, statistical procedures enable the researcher to organise, interpret and communicate the numeric results.
The independent variable (Indian and Knee-chest posture) is something that the experimenter purposely changes or varies over the course of the investigation. The dependent variable (Spontaneous cephalic version) is the one that is observed and likely changes in response to the independent variable.
Descriptive statistics will be used to describe and compare the participants of both groups, intervention and control. Participants will be compared by parity, maternal age and ethnicity using a cross-tabulation table before to analyse the results. These analyses are useful not only to assess the comparability of groups but also to describe the sample of participants who entered the study. Only those participants who completed the study will be included in the analysis. Participants who have not follow the study protocol or withdraw the study before the 36 weeks ultrasound scan will not be included.
The researcher will measure the central tendency of the distribution by calculating the mean (average), median (central tendency) and mode (most frequently appearing value) of each variable. Each variable will be turned into a numeric value.
The standard deviation will be calculated as it is used to identify if the attributes of those in two groups are closely matched, or whether they are different, and if so, how different. This is achieved by comparing the mean and the standard deviation in the two groups. Identical results are not expected. However, this results will show if both groups are reasonably close and if any discrepancies might make a difference to the interpretation of the result.
Once results are analysed and processed, inferential statistics will be used to determine if a postural management helps spontaneous cephalic version. An independent t-test will be carry out and results will be represented in a table. Independent T-test is used to compare the means of two separate groups. The table will compare the number and percentage of women with infants in a breech presentation in the intervention and the control group (shown as columns) at the enrolment of the study and at 36 weeks gestation (shown as rows).
To be more certain that the differences can not just be explained by chance, the researcher will process the data using a statistical test of significance. The results shown on the table will include a p value, which indicates whether the differences could have happened by chance. The smaller the likelihood that a difference could have happened by chance, the more certain we can be the intervention does produce the desired effect. P < 0.05 is regarded as the minimum value that may suggest a relationship between the independent and the dependent variable (Rees, 2012).
Participants will have the option to be provided with a summary of the results at the end of the study.
Results will be published in midwifery or medical journals and will be presented to relevant audiences at midwifery related conferences.
The NHS Research Ethics Committee and the Research and Development Committee at the Trust will be contacted for approval before the study commences.
According to the RCN (2007) the essential elements that must be observed by all researchers include:
– Informed consent. Written consent will be obtained following a clearly written information sheet explaining the nature of the study. This information sheet will be translate to others languages.
– Confidentiality. Steps will be taken to protect the identity of the participants by neither giving their name when presenting research results, nor including identifying details that might reveal their identity.
– Data protection. The researcher will store the data in such way that no unauthorised person can gain access to it. The researcher must follow the principles of the Data Protection Act 1998. This involves the right of individuals to see the information that is kept on them, and their right not to have that information passed on to another party.
– Right to withdraw. Participants will be asked if they would like to take part in research on the understanding that they have the right to refuse or, if they accept, can withdraw from the research at any time without any adverse consequences for the care they receive.
– Potential benefits and the potential harms. The researcher has an obligation to protect the rights and well-being of those involved in research. Previous studies have not reported any harm adopting an Indian or Knee-chest posture. Participants will be advised to stop the activities if any adverse event occurs.
Breech presentation of the infant during pregnancy is a risk factor for morbidity and mortality of both mother and infant. Evidence-based low risk methods to promote spontaneous cephalic version antenatally could be incorporated into routine midwifery care to avoid the risks of vaginal breech birth or the risks and cost of medical interventions, such as ECV and CS.
Critical evaluation of the literature on maternal posture for cephalic version of breech presentation in pregnancy found inadequate evidence for or against this clinical practice.
The lack of research support for the use of maternal posture to convert breech to cephalic presentation leads to a question of its efficacy and further research.
This randomized control trial for pregnant women with infants in breech presentation will investigate whether a postural management could be substantiated as an evidence-based practice to promote spontaneous conversion to cephalic presentation. There is support in the research literature to conduct the study.
DATA COLLECTION SHEET
Date of confirmed breech presentation:
Previous breech pregnancy: YES NO
Race / Ethnicity:
Obstetric Hx in current pregnancy
Previous medical Hx
(to be completed by the researcher)
Randomised to: Group 1 Group 2
Presentation at 36 weeks gestation:
Days of intervention:
Time of intervention (hrs./min.):
RECORD OF TIME FOR BREECH PREGNANCY STUDY
- Time start
- Time start
- Time start
Please comment any other physical activities during the day.
RECORD OF TIME FOR BREECH PREGNANCY STUDY
Please comment any physical activities during the day.
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