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Clinical Trials/ACTRN12612000040864
ACTRN12612000040864
Recruiting
Not Applicable

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.

Royal Prince Alfred Hospital0 sites200 target enrollmentJanuary 10, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post partum contraception
Sponsor
Royal Prince Alfred Hospital
Enrollment
200
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 10, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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