A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy. Randomised trial of systemic methotrexate versus laparoscopic salpingostomy in tubal pregnancy. Prostaglandin versus expectant management in early tubal pregnancy. Laparoscopic salpingostomy versus laparoscopic local methotrexate injection in the management of unruptured ectopic gestation. Randomized trial of conservative laparoscopic treatment and methotrexate administration in ectopic pregnancy and subsequent fertility. Fertility outcome after conservative surgical treatment of ectopic pregnancy evaluated in a randomized trial. Systemic methotrexate therapy versus laparoscopic salpingostomy in patients with tubal pregnancy. Part I. Impact on patients' health-related quality of life. Conservative management of ectopic pregnancy: prospective randomized clinical trial of methotrexate versus prostaglandin sulprostone by combined transvaginal and systemic administration. Laparoscopic surgery in ectopic pregnancy. A randomized trial versus laparotomy.
To compare single dose systemic methotrexate (50 mg/m2) with laparoscopic surgery for the treatment of unruptured tubal pregnancy.
                An open, pragmatic, prospective randomised trial.
                Departments of obstetrics and gynaecology at three hospitals in Auckland, New Zealand.
                Clinically stable women with an unruptured tubal pregnancy diagnosed by transvaginal ultrasound and quantitative serum beta-hCG measurement. Inclusion criteria included a serum beta-hCG concentration < 5,000 IU/L, and a tubal pregnancy of < 3.5 cm diameter.
                Treatment success, physical and psychological functioning, side effects, and subsequent ipsilateral tubal patency.
                Two hundred and eighteen women with ectopic pregnancies were seen at the three hospitals. 79 women (36% eligibility rate) were eligible for trial entry and 62 women (78% recruitment rate) were recruited. Twenty-six of the 28 women (93%) randomised to laparoscopic surgery required no further treatment, compared with 22 of the 34 women (65%) randomised to methotrexate (95% CI of difference in success rate 10 - 47%; P < 0.01). Two women (7%) in the laparoscopic surgery group had persistent trophoblast. Nine women (26%) in the methotrexate group required more than one dose of methotrexate and five women (15%) underwent laparoscopy during follow up. In the laparoscopy group three women (11%) had negative laparoscopies and two women (7%) had were found to have a ruptured fallopian tube at the time of surgery. Women treated with methotrexate had significantly better objective physical functioning scores but there were no differences in any other psychological outcomes. Women treated with methotrexate experienced greater and more prolonged vaginal bleeding. The likelihood of methotrexate treatment failure was greater at higher serum beta-hCG concentrations. Ipsilateral tubal patency rates were similar in each group.
                This trial shows that in the treatment of tubal pregnancy single dose systemic methotrexate is a less effective treatment than laparoscopic salpingotomy. It is well tolerated, but should only be offered as an alternative to surgery to women who have mild symptoms and present at low serum beta-hCG concentrations. In our population this likely to be no more than a quarter of women presenting with a tubal pregnancy. Laparoscopic salpingostomy is a well-established treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency.
                Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/kg oral folinic acid) or laparoscopic salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin < 2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat.
                100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic salpingostomy, 35 (72%) were successfully treated by laparoscopic salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the salpingostomy group (rate ratio 0.98 [95% CI 0.87-1.1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the salpingostomy group (rate ratio 0.93 [0.64-1.4]).
                In haemodynamically stable patients with unruptured tubal pregnancy, systemic methotrexate and laparoscopic salpingostomy were successful in treating the majority of cases. We found no significant difference between the treatments in the homolateral patency rate. Subsequent fertility outcome has to be awaited to show which treatment yields better fertility prospects. Since ectopic pregnancy may terminate in spontaneous recovery we compared treatment by means of prostaglandin (PG) application with expectant management in laparoscopically verified tubal gestations. Twelve patients received local and systemic PG, 4 patients were treated with sodium chloride and in 7 patients laparoscopy was discontinued without medical therapy. The comparison between the PG group and the placebo groups revealed a highly significant difference with regard to a subsequent necessary surgical intervention and hospitalisation. Expectant management may only be recommended in very selected cases, whereas PG treatment seems to produce favourable results in cases of early tubal pregnancy. Our goal was to determine whether laparoscopic salpingostomy is preferable to laparoscopic methotrexate injection in the management of unruptured tubal gestation.
                Forty-eight patients with unruptured tubal pregnancy were prospectively randomized to either laparoscopic salpingostomy or laparoscopic local methotrexate injection in a university medical center. Operation time, duration of hospital stay, decrease in levels of beta-human chorionic gonadotropin, and fertility outcome were compared between the two groups.
                The salpingostomy group had a longer operative time (p < 0.0001) but a shorter hospital stay (p < 0.01) and a lower incidence of persistent trophoblastic activity (5% vs 14%), although this difference did not reach statistical significance. The time interval until beta-human chorionic gonadotropin disappearance was similar (13.9 and 13.7 days), and the subsequent intrauterine pregnancy rate was similar in the two groups (83.5% and 81%). One repeat tubal pregnancy occurred in the salpingostomy group.
                Both these methods of conservative management are equally effective and each one has its merits. Methotrexate treatment was compared to laparoscopic salpingotomy for conservative management of ectopic pregnancy in a prospective randomized study. One hundred patients were randomized into two groups using random numbers. Inclusion criteria were an ectopic pregnancy visualized by ultrasound with a pre-therapeutic score <13 as assessed by the following six criteria, graded from 1 to 3: gestational age, human chorionic gonadotrophin (HCG) concentration, progesterone concentration, abdominal pain, haemoperitoneal volume and diameter of the haematosalpinx. The treatments were either 1 mg/kg of methotrexate injected transvaginally into the ectopic pregnancy without anaesthesia or administered i.m. when the pregnancy could not safely or easily be punctured (group 1), or laparoscopic salpingotomy (group 2). Success was defined as the return to normal (<10 mIU/ml) of HCG concentrations. Treatment was successful for 45 of 51 patients in group 1 (88.2%) and 47 of 49 in group 2 (95.9%). Medical treatment was significantly (P < 0.05) associated with shorter postoperative stay (24 compared with 46 h), but HCG returned to normal more quickly after laparoscopic treatment (13 compared with 29 days). Spontaneous reproductive performance was similar in both groups, but overall intrauterine pregnancy was higher, and repeat ectopic pregnancy lower, after methotrexate treatment. In selected cases of ectopic pregnancy, with a pre-therapeutic score <13, methotrexate treatment appeared as safe and efficient as conservative treatment by laparoscopy and was associated with improved subsequent fertility. To evaluate the fertility outcome after laparoscopic surgery for ectopic pregnancy.
                A randomized trial versus laparotomy was performed between May 1987 and June 1989.
                The study was conducted in a clinical university center, the Sahlgrens Hospital.
                A group of 105 patients with tubal pregnancy were stratified with regard to risk determinants and age and randomized to laparoscopy or laparotomy. Eighty-seven patients who desired pregnancy were evaluated for subsequent fertility outcome.
                Linear salpingotomy was performed in both surgical groups.
                We evaluated the fertility outcome after laparoscopic salpingotomy for comparison with the outcome after laparotomy.
                There was no difference between the groups in the overall fertility outcome. A substantially higher proportion of patients in the laparotomy group were subjected to adhesiolysis performed at a second-look laparoscopy.
                The fertility prospects are not impaired by laparoscopic surgery. Adhesiolysis at a second-look laparoscopy, especially after laparotomy, might be beneficial in selected cases and may serve to improve subsequent fertility. To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy.
                Multicenter randomized clinical trial.
                Departments of obstetrics and gynecology of six Dutch hospitals.
                Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic salpingostomy.
                Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy.
                Health-related quality of life.
                Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients.
                Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy. In a prospective randomized study, 21 patients with an unruptured tubal pregnancy were treated with local and systemic injection. On the day of diagnosis, methotrexate (MTX) (1 mg/kg) or sulprostone (500 micrograms) were injected into the gestational sac under transvaginal sonographic control. The systemic component consisted of an intramuscular injection of MTX (1 mg/kg) 3, 5, and 7 days after local injection or of sulprostone (500 micrograms) on the 1st 2 postlocal injection days. Methotrexate therapy was successful in 8 of 12 patients and sulprostone therapy in 6 of 9. Laparoscopy was then performed on the 7 unsuccessful patients: 3 of them had pain and hemoperitoneum and 4 of them had rising human choriogonadotropin (hCG) levels. One stomatitis after MTX and one cramping abdominal pain were observed. Thirteen of 14 successfully treated patients had initial hCG levels less than 5,000 mIU/mL. At subsequent hysterosalpinography, 13 of 14 patients had normal tubal configuration and patency. Three of 10 patients who desired another pregnancy had already achieved a normal intrauterine pregnancy. These results suggest that MTX and sulprostone were equally effective, and medical approach for the unruptured ectopic pregnancy may be restricted to patients with hCG less than 5,000 mIU/mL. A randomized, prospective clinical trial was conducted to compare the efficacy of laparoscopic treatment with conventional conservative abdominal surgery for tubal pregnancy. Entry criteria were: size of the ectopic gestation less than 4 cm, hemodynamic stability, accessibility for laparoscopic treatment and a trained laparoscopist on duty. There was no difference between the groups regarding gestational duration, size and location of the ectopic gestation, or the mean preoperative hCG values. The groups differed with respect to total operation time (73 min for the laparoscopy group vs. 88 min for the laparotomy group), hospital stay (2.2 vs. 5.4 days) and convalescence period (11 vs. 24 days). The rates of elimination of hCG was similar in the groups, and there were no statistical difference in the rate of second intervention.
In the surgical treatment of tubal ectopic pregnancy laparoscopic surgery is a cost effective treatment. An alternative non surgical treatment option in selected patients is medical treatment with systemic methotrexate. Expectant management can not be adequately evaluated yet.