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Trial registered on ANZCTR


Registration number
ACTRN12613001230741
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
8/11/2013
Date last updated
8/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can nurses offer early medical abortion as safely and effectively as physicians? A randomized controlled non-inferiority trial in Mexico City public legal abortion sites.
Scientific title
Can nurses complete medical abortions in women with a gestational age of 70 days or less as safely and effectively as physicians?
Secondary ID [1] 283253 0
A65785/ FCH/RHR
World Health Organization
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical Abortions
290128 0
Condition category
Condition code
Reproductive Health and Childbirth 290511 290511 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The allocated provider for the intervention group were nurses.

On day 1 clinical care and initiation of medical abortions (MA) from their allocated provider (nurses or physicians) began. This included counseling, a vaginal/pelvic exam, an abdominal ultrasound, and dispensation of 200mg of oral mifepristone taken on-site under provider supervision. Women were then given 800 micro grams of misoprostol (in 4 tablets of 200 micro grams each) with instructions to self –administer them buccally at home, 24 hours after the site visit. As part of the counseling women received on day 1, participants were provided with a card with instructions for contacting a study representative in the event of any questions or concerns, and were given an flyer containing information on expected side effects and also of potential serious events hat may require prompt medical attention, such as heavy bleeding, fever, and abnormal vaginal discharge. During the follow-up visit between days 7-15, abortion completion was assessed through a review of clinical symptoms and bleeding history and an abdominal ultrasound in order to confirm non-pregnancy, both administered by the assigned provider (nurse or phyrsician). When the process was deemed to be not yet complete, participants received an additional dose of 800 micro gramsof misoprostol (to be taken buccally at home) with a request to return for follow up one week later. If providers (nurses and physicians) felt a surgical intervention was warranted or if a woman requested it—a manual vacuum aspiration (MVA) was provided at the same site. All MVA procedures were carried out by an Ob-Gyn specialist, not part of the study.
Intervention code [1] 287984 0
Treatment: Drugs
Comparator / control treatment
The allocated provider for the control group were physicians.

A total of 932 women participated, 461 in the nurse-led arm and 471 in the physician-led arm. By comparing the number of completed abortions without surgical intervention by both nurses and physicians, we were able to determine if nurses can perform medical abortions to the same level as doctors.
Control group
Active

Outcomes
Primary outcome [1] 290530 0
Completed medical abortion without the need for surgical intervention was assessed by the assigned provider via a checklist review of clinical symptoms and bleeding history, and the results of abdominal ultrasound to confirm non-pregnancy.
Timepoint [1] 290530 0
7-15 days after administering misoprostol
Secondary outcome [1] 304744 0
Acceptability of nurses´s provision of medican abortion was assessed using 14 statements such as "How satisfied are you with the provider assigned to your MA?" and "The medical care you received from the provider assigned to your MA procedure in this health center / hospital was …"

Available answered differed by type of question such as:

Yes, no, and maybe

Very satisfied, Satisfied, Dissatisfied, No opinion

Better than what she expected, More or less what she expected, Does not know

Among others.

Timepoint [1] 304744 0
After abortion was completed

Eligibility
Key inclusion criteria
Eligible participants were women with a gestational age of 70 days or less and selected a medical abortion.
Minimum age
18 Years
Maximum age
44 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with a gestational age of more than 70 days.
Women who did not select a medical abortion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women who agreed to participate were taken to a private space in the facility where they were offered further information, given an opportunity to ask questions, and provided written consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To randomize participants to providers, in each site, we used a computer-generated randomization scheme. Sealed envelopes containing the random allocation, 0 (physician) or 1 (nurse), were assigned to each consecutive patient identification number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A non-inferiority design was used. The margin of non-inferiority was a priori determined to be 5%, meaning that nurses would be judged to be equivalent to physicians if the outcome of interest should were no more than 5% worse than outcomes for physicians. This margin of non-inferiority was based on clinically important differences and considerations of cost and feasibility. The sample size of, 800 (400 in each study arm), was sufficient to detect non-inferiority with 90% power, assuming a 5% loss to follow up rate. Non inferiority for this outcome was compared using the Intention to Treat (ITT) analysis.
The homogeneity of the three sites (strata) involved in this study was assessed using index H.
T-tests for two independent samples were used to assess significant differences in the means for physicians and for nurses across particular factors; for example, the mean difference of duration of gestation (by last menstrual period and ultrasound) of women attended by doctors and nurses.
In order to assess client acceptability across the two types of providers, we used responses to 14 questions on acceptability to compute an ad hoc score for each provider group. For each question the option representing the lowest acceptability received 0 points, and the option representing the highest received 1 point. Some of these questions could have been scored at 0.5. As such, the total score for each patient ranged between 0 and 14. The acceptability of each provider group was assessed comparing the mean of these total scores.

All analyses were conducted using SPSS v18 (SPSS Inc. Chicago, Illinois, USA), and WINPEPI (Abramson, J.H. WINPEPI updated: computer programs for epidemiologists, and their teaching potential. Epidemiologic Perspectives & Innovations 2011, 8:1).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5425 0
Mexico
State/province [1] 5425 0
Distrito Federal, Mexico City

Funding & Sponsors
Funding source category [1] 287992 0
Other
Name [1] 287992 0
World Health Organization
Address [1] 287992 0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Country [1] 287992 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
World Health Organization
Avenue Appia 20
1211 Geneva 27
Country
Switzerland
Secondary sponsor category [1] 286710 0
None
Name [1] 286710 0
nil
Address [1] 286710 0
nil
Country [1] 286710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289942 0
Mexico Ministry of Health
Ethics committee address [1] 289942 0
Lieja No. 7, Col. Juarez, Deleg. Cuauhtemoc

Distrito Federal CP. 06000
Ethics committee country [1] 289942 0
Mexico
Date submitted for ethics approval [1] 289942 0
Approval date [1] 289942 0
11/10/2011
Ethics approval number [1] 289942 0
A65785
Ethics committee name [2] 289956 0
Instituto Nacional de Salud Publica
Ethics committee address [2] 289956 0
Universidad No. 655 Colonia Santa Maria Ahuacatitlan, Cerrada Los Pinos y Caminera
C.P. 62100, Cuernavaca, Morelos
Ethics committee country [2] 289956 0
Mexico
Date submitted for ethics approval [2] 289956 0
Approval date [2] 289956 0
11/12/2011
Ethics approval number [2] 289956 0
1470-6771

Summary
Brief summary
Currently in Mexico City, medical abortion (MA) is only administered by physicians. Our study examines the effectiveness, safety, and acceptability of nurse-led provision of MA in comparison to that by physicians. The outcome of interest was completed medical abortion without the need for surgical intervention. The outcome was analyzed by intention-to-treat and per-protocol. A total of 932 women participated, 461 in the nurse-led arm and 471 in the physician-led arm. The study found that nurse-led provision of MA is no less safe, acceptable or effective as those led by physicians in Mexico City.
Trial website
Trial related presentations / publications
The results of this study have not been published or presented to date.
Public notes

Contacts
Principal investigator
Name 43074 0
Dr Claudia Diaz
Address 43074 0
Population Council
Insurgentes sur 2453- Torre Murano - 9 piso - Local 903
Col. Tizapan, Delegacion Alvaro Obregon, Mexico, D.F. 01090
Country 43074 0
Mexico
Phone 43074 0
(+52-55) 5999-8645
Fax 43074 0
Email 43074 0
cdiaz@popcouncil.org
Contact person for public queries
Name 43075 0
Dr Claudia Diaz
Address 43075 0
Population Council
Insurgentes sur 2453- Torre Murano - 9 piso - Local 903
Col. Tizapan, Delegacion Alvaro Obregon, Mexico, D.F. 01090
Country 43075 0
Mexico
Phone 43075 0
(+52-55) 5999-8645
Fax 43075 0
Email 43075 0
cdiaz@popcouncil.org
Contact person for scientific queries
Name 43076 0
Dr Claudia Diaz
Address 43076 0
Population Council
Insurgentes sur 2453- Torre Murano - 9 piso - Local 903
Col. Tizapan, Delegacion Alvaro Obregon, Mexico, D.F. 01090
Country 43076 0
Mexico
Phone 43076 0
(+52-55) 5999-8645
Fax 43076 0
Email 43076 0
cdiaz@popcouncil.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary