A pilot study on acceptability of intrauterine contraceptive devices and implanon post childbirth

A pilot study of women in the immediate post partum period examining the acceptability of intrauterine devices and implants, the continuity rates of both devices at 6 months and the expulsion rates of intrauterine devices.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000040864

Enrollment

100

Registered

2012-01-10

Start date

2012-04-18

Completion date

2019-12-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim is to undertake a pilot study to examine the acceptability, side effects and continuation rates of immediate post partum insertion of intrauterine devices and implants in women desiring long term but reversible contraception.

Interventions

This is a pilot cohort study in which women will be approached to take part in the antenatal or early post natal period and explained the advantages and disadvantages of immediate post partum insertion of an IUD or an implant. Women having an elective caesarean section can elect to either have an IUD device placed at the time of surgery or an implant placed in the postnatal ward. Women requiring an emergency caesarean section or those having a vaginal delivery will only be able to choose the implant for immediate postpartum insertion. Women in those groups wanting an IUD will be referred for interval insertion 6-12 weeks postpartum. We will follow women up clinically at 6 weeks and then at 6 months and 12 months via email or telephone contact. The implants can remain in place for up to 3 years, the intrauterine copper device (depending on the type) for 5-10 years and the intrauterine system for 5 years. These methods can be removed at any time if the woman experiences sides effects or wishes to conceive.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Women who are having an elective caesarean section (IUDs and implants) or are within 48 hours of a vaginal birth (implants only) Women who want immediate post partum contraception Women who consent to the procedure of IUD insertion Women who understand the additional potential risks of IUD expulsion and the theoretical but unproven risk of hormones on breast milk Women who are willing to present for a clinical follow up 6 weeks after discharge Women who are willing to be contacted after 6 and 12 months

Exclusion criteria

Exclusion criteria Women with abnormal uterine shape (congenital uterine anomalies or fibroids impinging on the uterine cavity) Women having an emergency caesarean section Women with allergy to copper, polyethylene or levonorgesterel Women with a current history of carcinoma in situ or cervical cancer Women with a diagnosis or receiving treatment for chorioamnionitis Women with prelabour rupture of membranes for more than 24 hours Women with postpartum haemorrhage as defined by need for transfusion, or an estimated blood loss greater than 1,000mL Women with premature rupture of membranes (pregnancy less than 34 weeks) Women with a history of sexually transmitted infection during pregnancy Women unable to understand English and consent to the procedure

Outcome results