Dahlke 2011.
| Methods | Location and time frame: Portsmouth, VA (USA), from August 2009 to January 2010 Design: RCT, pilot study Sample size calculation: Discussion notes study was not powered to detect difference in utilization at 6 months. Pilot study was planned to determined feasibility of later trial. |
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| Participants | General with N: 53 women in a single medical center Inclusion criteria: desired LNG‐IUS (Mirena, Bayer) for postpartum contraception at presentation for admission to labor and delivery and had no contraindication Exclusion criteria: congenital or acquired uterine anomaly including fibroids that distort uterine cavity; known or suspected uterine or cervical neoplasia or unresolved abnormal Pap smear; untreated acute cervicitis or known vaginitis including bacterial vaginosis or other lower genital tract infection; acute liver disease or liver tumor; hypersensitivity to any product component; and known or suspected carcinoma of breast Intrapartum exclusion: postpartum hemorrhage (blood loss > 500 mL); chorioamnionitis; cesarean delivery |
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| Interventions | LNG‐IUS insertion
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| Outcomes | Insertion, utilization rate, pain at time of placement, breastfeeding status, blood loss, intrauterine infection rate, expulsion rate Assessment times: 3 and 6 months post delivery by phone (n = 36) or record review (n = 7) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
| Allocation concealment (selection bias) | Low risk | Sealed, numbered opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding according to ClinicalTrials.gov listing |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: 2% (1 in standard group) Excluded after randomization because of cesarean section, as per trial criteria: 13% (2 each from immediate and early, 3 from standard) |