Comparison of modified introducer withdrawal technique with conventional manual technique of post placental intrauterine device insertion during cesarean section: a randomised controlled trial

RATIONALE

In this modified technique there is use of introducer withdrawal technique of IUCD insertion so that threads are directed to the cervical canal

Pushing the IUCDs unfolded arms up to the fundus with an introducer guarantees that the arms are securely in the uterine fundus

AIM

Comparison of modified introducer withdrawal technique of IUCD insertion versus conventional manual PPIUCD insertion technique during cesarean section on postpartum visibility of thread and correct placement of IUCD

OBJECTIVES

Primary objective

To compare visibility of thread at the end of puerperium at 6 weeks and three months between two techniques of PPIUCD insertion during cesarean section withdrawal technique versus conventional manual technique

To compare accuracy of fundal placement of IUCD after 1 week and 6 weeks of PPIUCD insertion between two techniques using ultrasound

Secondary objectives

To compare following conditions after 6 weeks and 3 months of PPIUD insertion by both techniques during cesarean section

1 Expulsion

2 Pain by VAS Scoring

3 Irregular Bleeding

4 Infection

To compare insertion time between 2 groups

MATERIALS AND METHODS

Study Design Randomised Control Trial

Setting The study will be conducted in the Department of Obstetrics and Gynaecology University College of Medical Sciences and Guru Teg Bahadur Hospital Dilshad Garden Delhi

Duration 1st August 2025 to 30th November 2026

Inclusion criteria

Pregnant women age 18 to 45 years planned for elective or emergency cesarean section consenting for an IUCD to be inserted immediately after placental removal

Exclusion criteria

Prolonged Ruptured Of Membranes more than 18 hours

Chorioamnionitis

Unresolved postpartum haemorrhage

Extensive genital trauma

Any contraindication for Cu IUCD

SAMPLE SIZE

The minimum sample size is estimated based on study conducted by Dabian et al reporting the outcome of interest considering visibility of threads were 885 percent in modified technique versus 603 percent in traditional method At two tail alternative hypothesis level of significance 5 percent power of test 95 percent and with equal allocations in both the groups the minimum sample size came out to be 130 including both the groups allocating 65 in each group

METHODOLOGY

Ethical clearance will be taken from the IEC HR

130 Pregnant women 18 to 45 years of age presenting with an indication for emergency or elective caesarean section and wants PPIUCD insertion will be randomized into two groups 65 each after written and informed consent Baseline demographics investigations like CBC URM GCT HIV Anti HCV VDRL LFT physical and obstetrics examination will be recorded

Group A will consist of 65 women who will receive PPIUCD insertion using the modified introducer withdrawal technique

Group B will consist of 65 women who will receive PPIUCD insertion using conventional manual technique

Follow up will be done at 7 to 10 days postpartum 6 weeks postpartum 3 months postpartum

Ultrasound will be done 7 to 10 days postpartum to confirm intracavitary position of IUCD and expulsion

At 6 weeks per speculum examination will be done to check visibility of threads Transvaginal ultrasound will also be done for correct placement and expulsion Women will be interviewed regarding any complaints

At 3 months postpartum per speculum examination will be done and ultrasound will be done if threads not visible to check expulsion Women will be interviewed regarding any complaints

OUTCOME MEASURES

Primary Outcome Measure

Percentage of women with visible threads on per speculum examination at 6 weeks and 3 months postpartum in both the groups and then comparison will be done

Percentage of women with normally placed PPIUCD at 7 days and 6 weeks postpartum in both the groups and then comparison will be done

Secondary Outcome Measures

Comparison of insertion time between two groups

Comparison of incidence of following conditions between two groups

1 Expulsion rate in percentage between two groups

2 Pain by VAS scale

3 Irregular bleeding

4 Infection

STATISTICAL ANALYSIS

Descriptive statistics based on qualitative and quantitative variables

The normality of the continuous data set will be assessed with Kolmogorov Smirnov test

Categorical variables will be analysed using the Chi square test

P value less than 005 will be considered statistically significant

All the analysis will be performed by using SPSS version 200