Clinical trial NCT01807715: Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion
Official title: Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Abortion
Keywords: first trimester
surgical abortion
contraception
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking first trimester surgical abortion

Brief summary: The investigators will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. The investigators will ask the staff at each facility to offer a survey to all women 18 and older presenting to the clinic to have a first trimester (\<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. The investigators hope to implement the survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target population of 600 women receiving surgical first trimester abortions at these two clinics over a 3-4 month period with a 95% confidence interval).

Detailed description: We will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. We will introduce the research project to clinic staff, recruiting their support and participation, as they will be the main implementers. The survey will be offered to women in the waiting room before any pre-procedure counseling. We will include all women presenting to the clinic who are 18 years and older and planning to have a first trimester (\<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. We hope to implement the survey at these two clinics for 3-4 months reaching a minimum of 200 women so as to obtain an adequate power for our study. The brief survey will include a cover letter explaining the study and stressing the anonymity and confidentiality. The surveys will include an envelope in which to place completed surveys; the envelope can be sealed by the participant and dropped in a collection bin. This process will allow the data to be collected anonymously. The survey data will then be synthesized first by descriptive analysis, followed by chi-square and multiple regression analyses. A statistician in the University of California Davis Department of Obstetrics and Gynecology will help when necessary.

Eligibility criteria: Inclusion Criteria:

* seeking first trimester surgical abortion

Exclusion Criteria:

* Women who cannot understand or read the survey

Primary outcomes:
measure: patient preference
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: UC Davis
name: Mitchell D Creinin, MD
role: STUDY_DIRECTOR
affiliation: UC Davis
name: Melissa Matulich
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matulich M, Cansino C, Culwell KR, Creinin MD. Understanding women's desires for contraceptive counseling at the time of first-trimester surgical abortion. Contraception. 2014 Jan;89(1):36-41. doi: 10.1016/j.contraception.2013.09.013. Epub 2013 Sep 30.