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

Recruiting

• Conditions: Post partum contraception; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12612000040864
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To document the safety and acceptability of intrauterine devices and implants inserted immediately post partum.[At 6 weeks the woman will be assessed clinically to confirm that the device is correctly placed and to document any any side effects experienced to that point. Women will also be asked to complete a questionnaire about their satisfaction with the method. At 6 and 12 months post partum women will be contacted via email or telephone and asked to complete a questionnaire to record side effects and satisfaction with the method.]

Secondary Outcome Measures

Name	Time	Method
To determine ongoing use of these methods at 12 months[Women will be contacted at 6 and 12 months post partum via email or phone and asked to complete a structure questionnaire about their continued use of their chosen method and if they have ceased using the method what were the primary reasons]