Goldman 2004.
Methods | 2‐year cohort study of women undergoing surgically induced abortion in 2 clinics | |
Participants | 1393 women completed the study The study was carried out in the USA – in New Hampshire and Vermont clinic facilities All women who underwent an outpatient surgical abortion performed by a physician at the Feminist Health Center of Portsmouth, New Hampshire, or by a physician assistant at the Vermont Women's Health Center in Burlington, Vermont, between July 1996 and October 1997 were eligible There were no restrictions on gestational age but the majority were in the 1st trimester |
|
Interventions | Physicians with at least 5 years experience in abortion procedures performed standard vacuum curettage procedures for pregnancies up to 12 weeks gestation at a clinic in New Hampshire Physician assistants with the same level of experience provided MVA or standard vacuum curettage procedures for pregnancies up to 14 weeks gestation at a clinic in Vermont Follow‐up was within 14 days of the procedure |
|
Outcomes | Complications: Complications were defined according to National Abortion Federation guidelines as follows: ‐ Incomplete abortion, in which tissue from the pregnancy remains in the uterus, requiring a repeat abortion ‐ Failed abortion (continued pregnancy), in which the abortion does not end the pregnancy, requiring a repeat abortion ‐ Ectopic/extrauterine pregnancy, in which the signs and symptoms of pregnancy continue after abortion but no intrauterine pregnancy is detected ‐ Perforation, a condition in which a puncture or tear in the wall of the uterus or other organ is present ‐ Cervical laceration, a condition in which a tear in the cervix is present, requiring either sutures or vaginal packing ‐ Infection, which is detected by a temperature elevated to 100.4 °F or 38.0 °C, lower abdominal pain or tenderness, and abnormal cervical discharge ‐ Haemorrhage, defined as blood loss estimated as 500 cc or greater (defined as bleeding that was heavier than the heaviest day of a normal menstrual period or that soaked through more than 1 sanitary pad per hour), which is caused by failure of the uterus to contract and may require a blood transfusion ‐ Other complications, including shock, coma, amniotic fluid embolism, anaesthesia‐related Complications were further classified as either immediate or delayed Immediate complications were defined as those that occurred during the procedure or before discharge from the clinic. Delayed complications were those that occurred up to 2 weeks after discharge difficulties, and death |
|
Notes | All procedures performed by the physicians in New Hampshire were standard vacuum curettage, whereas more than half of the physician assistant procedures (virtually all of those performed at 8 weeks gestation or earlier) were manual vacuum curettage The cannula sizes used by the 2 clinics differed. In Vermont, 95% of the manual vacuum curettage procedures performed at 8 weeks gestation or earlier were performed with a 5 mm or 6 mm cannula. By contrast, in New Hampshire 96% of the standard vacuum curettage procedures performed at 8 weeks gestation or earlier were performed with a 7 mm, 8 mm or 9 mm cannula |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | None. 2 clinics in 2 different US states: providers in New Hampshire were physicians, providers in Vermont were physician assistants. Characteristics of the participants differed between the 2 settings |
Allocation concealment (selection bias) | High risk | None |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participant was aware of the provider type. We do not consider this to be a bias because this is part of the intervention. If MLPs are to perform abortion procedures outside of study conditions, we would expect patients to be aware of the provider type. We therefore do not consider the lack of blinding to provider type to bias the results of the study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | None |
Incomplete outcome data (attrition bias) All outcomes | High risk | 28.5% loss to follow‐up – delayed complication data are likely to be affected |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | High risk | Physician assistants and physicians differed in the methods of abortion used Clinician training varied between clinics |