RecruitingACTRN12614000558628

Uterine cavity length in postpartum women who are exclusively breastfeeding: is atrophy responsible for a higher perforation rate at Intrauterine Contraceptive Device (IUCD) insertion?

Do breast feeding women 2-6 months postpartum have a shorter intrauterine cavity length when measured on transvaginal ultrasound scan, compared with non breastfeeding women 2-6 months postpartum and non breastfeeding women greater than 6 months postpartum.


Sponsor

Dr Helen Paterson

Enrollment

66 participants

Start Date

Jan 1, 2014

Study Type

Observational

Conditions

Summary

Postpartum breastfeeding women have a higher risk of uterine perforation with insertion of an intrauterine contraception device (IUD). The mechanism for this is unknown, we hypothesize that a reduction in uterine cavity length is responsible for the increased perforation rate. Perforation is a serious complication, which requires surgery to remove the perforated IUD, resulting in a significant cost to the woman and the health service. Our objective is to compare uterine cavity length in exclusively breastfeeding women with non-breastfeeding women. A smaller sized cavity may explain the increased risk of perforation in breastfeeding women, leading to a change in practice.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

Women who are breastfeeding have a higher chance of experiencing a serious complication — called uterine perforation — when a doctor inserts an intrauterine device (IUD) for contraception. Researchers think this may happen because breastfeeding causes hormonal changes that shrink the uterus. This study compares the size of the uterine cavity in breastfeeding women, bottle-feeding women, and women who stopped breastfeeding at least two months ago, to find out whether a smaller uterus explains the higher perforation risk. You may be eligible if: - You have given birth at least once - You fall into one of these groups: (1) more than 6 months postpartum and not breastfeeding for at least 2 months; (2) 2–6 months postpartum and exclusively breastfeeding with no periods; or (3) 2–6 months postpartum and bottle-feeding from 6 weeks You may NOT be eligible if: - You have known uterine problems such as fibroids or an unusually shaped uterus - You have never given birth - You currently have an IUD in place - You are using hormonal contraception - You are pregnant Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Observational study - comparing intrauterine cavity length & fundal myometrial thickness in breastfeeding women 2-6 months postpartum with non breastfeeding women 2-6 months postpartum and non-breastf

Observational study - comparing intrauterine cavity length & fundal myometrial thickness in breastfeeding women 2-6 months postpartum with non breastfeeding women 2-6 months postpartum and non-breastfeeding women greater than 6month postpartum and premenopausal by using a single cross-sectional transvaginal ultrasound measurement.


Locations(1)

New Zealand

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ACTRN12614000558628