Effect of antenatal perineal massage on vaginal birth related perineal trauma in primiparae -Randomised control trial

Intrapartum injuries are a topic of concern for women during childbirth especially those who are   conceiving for the first time. It occur as a result of inelastic perineum ,long second stage of labor ,inadequate perineal support and large size of baby. Perinatal injuries can cause short term and long term complications .It includes bleeding, pain ,infections ,hematoma and discomfort in early post partum period  . It can also result in urinary and fecal incontinence in long term   .It also affects the quality of life and are known to cause sexual dysfunction in women.

Antepartum perineal massage reduces the risk of intrapartum tears, perineal pain and rate of episiotomies during labor. Many international studies are already done which support this but there is scarcity of Indian data.

HYPOTHESISAntepartum perineal massage is effective in decreasing the frequency of vaginal birth related perineal injuries in primiparae as compared to women who do not receive antepartum perineal massage .

AIM To study the effect of antepartum perineal massage on vaginal birth related perineal trauma .

PRIMARY OBJECTIVETo compare the frequency of perineal tears, in women who will receive antepartum perineal message as compared to women who will not receive antepartum perineal massage.

SECONDARY OBJECTIVE To compare the duration of 2nd stage of labor(in minutes), rates of episiotomy and perineal pain  at  48 hours  in postpartum period in study and control group .

This study will be carried out after prior approval from the Institutional Ethical and Research committee.

STUDY DESIGN- Randomised control trial

PLACE OF STUDY-ANC OPD of obstetrics and gynaecology at   Lady Hardinge medical college and SSK hospital, Delhi

INCLUSION CRITERIA All low risk primigravida  between  34-36 weeks of gestation with single live fetus in cephalic presentation between the age of 18 and 35 years.

EXCLUSION CRITERIA

All high risk primigravida .

All primigravida with diagnosed pelvic floor dysfunction and preexisting genital infections.

Previous history of perineal trauma and   Expected fetal  weight more than 95th centile for that gestation

SAMPLE SIZE ESTIMATION- 55 per group

METHODOLOGY

An informed consent will be taken from all the eligible women fulfilling inclusion criteria .The participants will be selected in both groups based on systematic random sampling technique.

Participants will be explained about benefits and technique of antepartum perineal message using pictorial charts.

Randomization: Using sequential computer-generated block randomization (block size of four) study participants will be divided into two groups, study group (receiving intervention of antepartum perineal massage) and control group (not receiving antepartum perineal massage), with 1:1 allocation ratio. Allocation will be concealed with the use of sequential numbered opaque envelopes. Allocation will be done by candidate. Participants & investigator delivering intervention as well as assessing outcome will be aware about the intervention being received. Data Analyst will be blinded to the allocation.

Detailed history will be taken and detailed examination including ,general physical examination  ,systemic examination ,obstetric examination  will be  done.

They will be given supervised session of antepartum massage at every OPD visit and explained to perform the same at home .

They are asked to give self massage at home once before next visit .Enrolled women will be followed up weekly and then compliance will be checked.

Antepartum perineal  massage will be done  twice a week for 10 mins  till delivery.

Control group will not receive antepartum perineal massage.

Both the groups will be managed as per standard protocol and followed up  weekly till  delivery and 48hrs postpartum .

All women who will have Preterm vaginal delivery and LSCS  will be excluded from the study.

Normal vaginal delivery will be conducted by  residents posted in labor room and  trained in conducting vaginal deliveries.

Delivery details and duration of second stage of labor ( in minutes) will be recorded , it lasts for 2 hours in nulliparas (median 50 minutes).

Assessment of pain will be done at 48 hours postpartum using VAS Pain score of (1-10).The mean pain score of two groups will be calculated .

The visual analog scale(VAS) is a validated, subjective measure for pain. Scores are recorded by making mark on a 10-cm line that represents a continuum between “no pain” and “worst pain”. The VAS takes < 1minute to complete.

The data will be subjected to statistical analysis.

STEPS OF ANTEPARTUM PERINEAL MASSAGE

Women will be asked to lie in comfortable and relaxed position .Propped  up position with  back supported and wide apart legs flexed at knees and hip joint.

Researcher will do antepartum massage under all aseptic precaution with gloved hands and using 2% lignocaine jelly, thumbs of both hands will be inserted  in the vagina to a depth of 3 to 5 cms and pressed down towards the anus and to the sides of the vaginal walls. The  thumbs will be held in this position for about 1 minute  until a slight burning ,tingling sensation is felt .

Gentle massage will be done in the lower half of vagina using a U shaped movement for 2-3 minutes and repeated 2-3 times.

Massage can be done in one direction at a time i.e. from side to side or the thumbs can be swept in opposite direction. The message will be done for 10 minutes

Simultaneously relaxed breathing is advised to relax the pelvic floor muscles and allowing the tissues to stretch.

Women will be advised to repeat the massage once at home before coming to next OPD visit . They are advised to wash hands and can use a lubricant like coconut oil .