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. 2019 Apr 23;2019(4):CD004317. doi: 10.1002/14651858.CD004317.pub5

Canto De Cetina 2001.

Methods Single site, parallel group RCT
Location: 1 site at 'Centro de Investigaciones Hideyo Noguchi,' Merida, Yucatan (Mexico)
Time frame: no information
Sample size calculation (and outcome of focus): no information
Participants General with N: 350 women attending the Family Planning Clinic and willing to use DMPA for contraception
Inclusion criteria:

  • 18 to 35 years old;

  • living in rural area;

  • proven fertility;

  • regular menstrual cycles during previous 6 months;

  • not breastfeeding;

  • at least 1 child;

  • normal Pap smear;

  • willing to use DMPA as only contraceptive agent during study;

  • willing to return to clinic every 3 months.


Exclusion criteria:

  • current or history of thrombophlebitis;

  • thromboembolic disorders;

  • hypertension;

  • cerebral vascular disease;

  • active or chronic liver disease;

  • known or suspected breast or genital organ malignancy;

  • endocrinopathy undiagnosed;

  • vaginal bleeding;

  • diabetes mellitus.
Interventions Intervention:

  • Structured pretreatment and follow‐up counseling


Comparison:

  • Routine pretreatment counseling
Outcomes Cumulative life table discontinuation rate, reason for discontinuation, DMPA‐induced side effects
Follow‐up visits coincided with injection time (every 3 months for 1 year).
Notes Trial registration: not stated
Funding: not stated
Declarations of interest: no details provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants "were randomized to receive either structured counseling or routine indications". No further information provided.
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No details provided of blinding of participants or 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 Low risk Loss to follow‐up: Counseling group, 1%; Control group, 2%
Selective reporting (reporting bias) High risk No protocol was available.
Continuation/discontinuation was the only prespecified outcome in the manuscript. A number of other outcomes were reported in the manuscript.
Other bias Unclear risk Did not report any objective outcome measures