Skip to main content
. 2019 Apr 23;2019(4):CD004317. doi: 10.1002/14651858.CD004317.pub5

Gilliam 2004.

Methods Single site, parallel group RCT
Location: Hospital in Chicago, IL, USA
Time frame: 1998 to 1999
Sample size estimation and outcome of focus: not mentioned until discussion; sample size not sufficient to detect 20% difference between groups, due to resource limitations
Participants General with N: 33 African American low‐income females attending Prentice Ambulatory Care; resident‐run clinic served low‐income women receiving public assistance
Inclusion criteria:
  • 25 years or younger;

  • with unplanned pregnancy;

  • intending to use OCs postpartum.


Exclusion criteria:
  • history of consistent or successful oral contraceptive (OC) use prior to pregnancy.

Interventions Intervention:
  • Post‐delivery, multi‐component intervention consisting of counseling, videotape about OCs, and written material in addition to usual care, provided prior to hospital discharge.


Comparison:
  • Usual care ‐ prior to discharge, all participants received standard postpartum counseling. Residents discussed how to take the pill, what to do if a pill is missed, side effects and risks and benefits of OCs.


All participants received 3 labelled pill packets with instructions and telephone numbers for 24‐hour access if they had questions.
Outcomes Continuation rate, switch to other contraceptives; pregnancy for 9 women (from delivery records or self‐report)
Follow‐up: 1 year
Notes Knowledge of OCs mentioned, but data reported elsewhere
43 women enrolled in Chicago study but only 33 randomized. Reasons for enrolment without randomization included participants changing their mind about using OCs, delivering at an outside hospital, and failure of study team to randomize participant prior to leaving hospital due to miscommunication with nursing staff or leaving after 24‐hour rather than 48‐hour stay.
Trial registration: not stated
Funding: Trial supported by a grant from the American College of Obstetricians and Gynecologists and Park‐Davis Research Award in Contraception
Declarations of interest: no details provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers table; randomized following delivery
Allocation concealment (selection bias) Low risk Study packets were in envelopes that "concealed the contents"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Research team members reportedly blinded to group participation.
No details provided of blinding of intervention providers; not feasible due to type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: 52% dropped out by 1 year; data on OC use for 76% (25/33) and on OC knowledge for 42% (14/33)
Pregnancy data for 9 who dropped out from records or contacting participants; data loss 8/33 = 24%
Selective reporting (reporting bias) Unclear risk No protocol was available, however, all outcomes prespecified in the manuscript were reported.
Other bias Unclear risk Did not report any objective outcome measures