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. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3

WHO 1980.

Methods Location and time frame: Hungary, Belgium, Brazil, United Kingdom, Chile, and Germany
Design: RCT at 6 centers
Sample size calculation and outcome of focus: no mention
Participants General with N: 841 healthy women
Inclusion criteria: aged 16 to 40 years; having vaginal delivery; willing to rely on IUD for fertility regulation
Exclusion criteria: recent history of pelvic inflammatory disease; sexually transmitted infection treated during current pregnancy; congenital abnormality of uterus or vagina; known or suspected genital tract malignancy; uterine fibroids; or evidence of infection during labor
Interventions IUD inserted immediately after expulsion of placenta
  • Copper 7 (Gravigard)

  • Lippes Loop D

  • Postpartum T (T‐shaped IUD with two extra arms, 2‐cm long, extending up and out from lower end of vertical stem)


Insertions were done with standard or modified IUD inserter or by manual placement at fundus.
Outcomes Reported expulsion (partial or complete), pregnancy, removal for bleeding or pain, and other medical removal
Assessment times: 6 and 12 months; follow‐up to 24 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization by computer‐generated table of numbers (from communication with investigators)
Allocation concealment (selection bias) Low risk Sealed, opaque, sequentially numbered envelopes with method indicator card (from communication with investigators)
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Trial was stopped prematurely because expulsion rates with all devices exceeded predetermined 20% limit. Women with expulsion within 48 hours after insertion were excluded from life‐table analysis (part of protocol).
Loss to follow‐up (reported; time frame unclear): Postpartum T, 17.8%; Lippes Loop, 16.2%; Copper 7, 16%