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P J Hajenius

Publications and source records attributed to P J Hajenius.

At least 19 recordsLinked to original sources
PubMed2001

Non-invasive management of patients with suspected ectopic pregnancy: a survey among Dutch gynaecologists.

OBJECTIVE: To investigate if implementation of a non-invasive diagnostic work up of patients with suspected ectopic pregnancy, involving transvaginal sonography and serum human chorionic gonadotrophin (hCG) measurement decreases the likelihood of performing diagnostic laparoscopies. STUDY DESIGN: We interviewed 27 Dutch gynaecologists using 16 structured case summaries in a fractional factorial design. Each case summary concerned a hypothetical patient with suspected ectopic pregnancy. For each case presentation, the gynaecologists were asked for their inclination to perform laparoscopy. RESULTS: There were substantial differences in the degree to which data from a non-invasive work-up influenced the decision to perform a laparoscopy. Some gynaecologists would perform laparoscopy in all 16 patients at the first visit, whereas others would initially admit none of them. CONCLUSION: Dutch gynaecologists seem to be familiar with a non-invasive diagnostic approach in women with suspected ectopic pregnancy. However, there are considerable differences in management approach probably due to individual variability in weighing the risks and benefits of expectant management.

Chorionic Gonadotropin↗
PubMed2000

Interventions for tubal ectopic pregnancy.

BACKGROUND: The diagnosis of ectopic pregnancy can now often be made by non-invasive methods due to sensitive pregnancy tests (in urine and serum) and high resolution transvaginal sonography, which have been integrated in diagnostic algorithms. These algorithms, in combination with the increased awareness and knowledge of risk factors among both clinicians and patients, have enabled an early and accurate diagnosis of ectopic pregnancy. As a consequence, the clinical presentation of ectopic pregnancy has changed from a life threatening disease to a more benign condition. This in turn has resulted in major changes in the options available for therapeutic management. Many treatment options are now available to the clinician in the treatment of tubal pregnancy: surgical treatment, which can be performed radically or conservatively, either laparoscopically or by an open surgical procedure; medical treatment, with a variety of drugs, that can be administered systemically and/or locally by different routes (transvaginally under sonographic guidance or under laparoscopic guidance); expectant management. The choice of a treatment modality should be based on short-term outcome measures (primary treatment success and reinterventions for clinical symptoms or persistent trophoblast) and on long-term outcome measures (tubal patency and future fertility). OBJECTIVES: In the treatment of tubal pregnancy various types of treatments are available: surgical treatment, medical treatment and expectant management. In this review the effects of various treatments are summarized in terms of treatment success, need for reinterventions, tubal patency and future fertility. SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group trials register and MEDLINE were searched. SELECTION CRITERIA: Randomized controlled trials comparing treatments in women with ectopic pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data extracted independently by two reviewers. Differences were resolved by discussion with all reviewers. MAIN RESULTS: Laparoscopic conservative surgery is significantly less successful than the open surgical approach in the elimination of tubal pregnancy due to a higher persistent trophoblast rate of laparoscopic surgery. Long term follow-up shows similar tubal patency rates, whereas the number of subsequent intrauterine pregnancies is comparable, and the number of repeat ectopic pregnancies lower, although these differences are not statistically significant. The laparoscopic approach is less costly as a result of significantly less blood loss and analgesic requirement, and a shorter duration of operation time, hospital stay, and convalescence time. Compared to laparoscopic conservative surgery (salpingostomy) local methotrexate is not a treatment option. Injection of this drug, both under laparoscopic guidance and under ultrasound guidance, is significantly less successful in the elimination of tubal pregnancy. Systemic methotrexate in a single dose intramuscular regimen is not effective enough in eliminating the tubal pregnancy compared to laparoscopic salpingostomy. This as a result of inadequately declining serum hCG concentrations after one single dose of methotrexate necessitating additional methotrexate injections or surgical interventions. If methotrexate primarily given in a multiple dose intramuscular regimen is compared with laparoscopic salpingostomy no large differences are found in medical outcomes, both short term and long term. However, this treatment regimen is associated with a greater impairment of health related quality of life and is more expensive, due to surgical interventions for clinical signs of tubal rupture, generating additional direct costs due to prolonged hospital stay. Furthermore, indirect costs due to productivity loss are higher. Only in patients with low initial serum hCG concentrations systemic methotrexate leads to costs savings compared to laparoscopic salpingostomy.

Female↗
PubMed1999

Treatment of tubal pregnancy in the netherlands: an economic comparison of systemic methotrexate administration and laparoscopic salpingostomy.

OBJECTIVE: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic salpingostomy for the treatment of patients with tubal pregnancy. STUDY DESIGN: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. RESULTS: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was <1500 IU/L, a cutoff value that had not been previously hypothesized. In a scenario without a confirmatory laparoscopy, in which transvaginal ultrasonography and serial repeated serum human chorionic gonadotropin measurements were assumed to be as accurate as laparoscopy, systemic methotrexate therapy would have reduced total cost by $1500 for a patient with an initial serum human chorionic gonadotropin concentration of <1500 IU/L. In such a scenario total costs would have been similar for a patient with an initial serum human chorionic gonadotropin concentration in the range of 1500 to 3000 IU/L, whereas systemic methotrexate administration would be more costly for a patient with an initial serum human chorionic gonadotropin concentration of >3000 IU/L. CONCLUSIONS: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy.

Chorionic Gonadotropin↗
PubMed1999

Should patients who are suspected of having an ectopic pregnancy undergo physical examination?

OBJECTIVE: To determine whether physical examination is useful for patients with suspected ectopic pregnancy (EP) for whom transvaginal sonography is performed and serum hCG levels are measured. DESIGN: Prospective study. SETTING: Two large teaching hospitals. PATIENT(S): Three hundred eighty-two patients with suspected EP, based on a positive urine pregnancy test and the presence of abdominal pain, vaginal bleeding, or risk indicators. INTERVENTION(S): Abdominal examination, speculum inspection, and digital vaginal examination. MAIN OUTCOME MEASURE: A final diagnosis made by transvaginal sonography, serum hCG measurement, and, if necessary, confirmatory laparoscopy. RESULT(S): One hundred sixteen (30%) of the 382 patients had an EP. At external abdominal examination, rebound tenderness and muscular rigidity had likelihood ratios of 3.7 and 8.0, respectively. Findings at speculum inspection and digital vaginal examination had likelihood ratios between 0.33 and 2.4. Logistic regression analysis showed that the additional information provided by physical examination for the diagnosis of EP is limited compared with the information provided by transvaginal sonography and serum hCG measurement alone. CONCLUSION: On the basis of our results, we believe that vaginal digital examination for patients with suspected EP is unnecessary.

Adult↗
PubMed1999

Can noninvasive diagnostic tools predict tubal rupture or active bleeding in patients with tubal pregnancy?

OBJECTIVE: To evaluate the ability of noninvasive diagnostic tools to predict tubal rupture and active bleeding in patients with tubal pregnancy. DESIGN: Prospective cohort study. SETTING: Two large teaching hospitals in Amsterdam, The Netherlands. PATIENT(S): Consecutively seen patients with suspected tubal pregnancy who were scheduled to undergo confirmative laparoscopy. MAIN OUTCOME MEASURE(S): Tubal rupture and/or active bleeding confirmed at laparoscopy. RESULT(S): Sixty-five (23%) of 288 patients had tubal rupture and/or active bleeding at laparoscopy. Abdominal pain, rebound tenderness on abdominal examination, fluid in the pouch of Douglas at transvaginal ultrasound examination, and a low serum hemoglobin level were independent predictors of tubal rupture and/or active bleeding. Pregnancy achieved with the use of IVF-ET and the presence of an ectopic gestational sac or an ectopic mass at ultrasound examination reduced the risk of tubal rupture. Abdominal pain was the most sensitive predictor, with a sensitivity of 95%. CONCLUSION(S): Because the nonsurgical management of tubal pregnancy should be used only when the risk of tubal rupture and/or active bleeding is low, it can be safely applied in only a limited number of patients.

Adult↗
PubMed1999

Are gestational age and endometrial thickness alternatives for serum human chorionic gonadotropin as criteria for the diagnosis of ectopic pregnancy?

OBJECTIVE: To compare gestational age and endometrial stripe thickness measurement with serum hCG measurement as criteria for the diagnosis of ectopic pregnancy (EP). DESIGN: Prospective study. SETTING: Two large teaching hospitals in Amsterdam, The Netherlands. PATIENT(S): Three hundred fifty-four consecutively seen pregnant patients who presented between September 1993 and April 1996 with suspected EP and in whom transvaginal ultrasonogram showed no intrauterine pregnancy or EP. Ultrasonography was performed by one of the study investigators or, during shifts, by the resident on call. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The accuracy of gestational age, endometrial stripe thickness, and serum hCG measurement in the diagnosis of EP was evaluated with receiver operating characteristic curve analysis. RESULT(S): Gestational age and endometrial stripe thickness could not discriminate between patients with EP and patients without EP, whereas serum hCG had an acceptable area under the receiver operating characteristic curve. CONCLUSION(S): Gestational age and endometrial thickness are not useful in the diagnosis of EP. Serum hCG measurement is the diagnostic instrument of choice in patients with suspected EP when transvaginal ultrasonography does not reveal a diagnosis.

Adult↗
PubMed1998

Are serum human chorionic gonadotropin clearance curves of use in monitoring methotrexate treatment in cervical pregnancy?

OBJECTIVE: To describe the monitoring of an unsuccessful case of methotrexate treatment of cervical pregnancy. DESIGN: Case report. SETTING: University hospital. PATIENT(S): A 27-year-old woman, gravida 3, para 1, with a vital cervical pregnancy. INTERVENTION(S): Feticide and methotrexate administered both locally and systemically. MAIN OUTCOME MEASURE(S): Treatment success, defined as elimination of the cervical pregnancy with preservation of the uterus. RESULT(S): Despite reassuringly declining serum hCG concentrations, several episodes of severe vaginal bleeding demanded transfusions of 19 U of packed cells, two angiographic embolizations that were complicated by septicemia, and a balloon catheter tamponade followed by a third angiographic embolization. Ultimately, a hysterectomy was necessary because of uncontrollable vaginal bleeding. CONCLUSION(S): This case report shows that serum hCG monitoring was not helpful in the detection of impending treatment failure. Currently, no guidelines are available to clinicians for predicting treatment failure of methotrexate in patients with cervical pregnancy. Serum hCG clearance curves do enable the timely detection of inadequately declining serum hCG concentrations, for which additional methotrexate can be administered.

Adult↗
PubMed1998

Systemic methotrexate therapy versus laparoscopic salpingostomy in patients with tubal pregnancy. Part I. Impact on patients' health-related quality of life.

OBJECTIVE: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy. DESIGN: Multicenter randomized clinical trial. SETTING: Departments of obstetrics and gynecology of six Dutch hospitals. PATIENT(S): 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. INTERVENTION(S): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy. MAIN OUTCOME MEASURE(S): Health-related quality of life. RESULT(S): 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. CONCLUSION(S): 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.

Adaptation, Psychological↗
PubMed1998

Systemic methotrexate therapy versus laparoscopic salpingostomy in tubal pregnancy. Part II. Patient preferences for systemic methotrexate.

OBJECTIVE: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic salpingostomy in the treatment of tubal pregnancy. DESIGN: Preference assessment in controlled clinical study. SETTING: Four hospitals and one infertility clinic. PATIENT(S): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. INTERVENTION(S): Preference for methotrexate therapy relative to salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. MAIN OUTCOME MEASURE(S): Preference for systemic methotrexate therapy. RESULT(S): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. CONCLUSION(S): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.

Adult↗
PubMed1998

Serum human chorionic gonadotropin measurement in the diagnosis of ectopic pregnancy when transvaginal sonography is inconclusive.

OBJECTIVE: To assess the accuracy of initial and repeated serum hCG measurements in the diagnosis of ectopic pregnancy (EP) in patients in whom transvaginal sonography is inconclusive and to evaluate whether patient characteristics influence the accuracy of serum hCG measurements. DESIGN: Prospective study. SETTING: Two large teaching hospitals in Amsterdam, the Netherlands. PATIENT(S): Three hundred fifty-four consecutively seen pregnant patients with suspected EP and inconclusive transvaginal sonographic findings. INTERVENTION(S): Serum hCG measurements. MAIN OUTCOME MEASURE(S): The performance of repeated serum hCG measurements in the diagnosis of EP was evaluated through the analysis of receiver operating characteristic curves. RESULT(S): Initial serum hCG measurements were more diagnostic in conjunction with sonographic evidence of an ectopic mass or fluid in the pouch of Douglas than in the absence of sonographic abnormalities. On repeated measurement, the course of the serum hCG concentration provided more diagnostic information than did the absolute serum hCG concentration 2 and 4 days after the start of the diagnostic process. CONCLUSION(S): The interpretation of serum hCG measurements should depend on additional findings at transvaginal sonography. A cutoff level of 1,500 IU/L is recommended for patients with an ectopic mass or fluid in the pouch of Douglas; in patients without these findings, the cutoff level should be at least 2,000 IU/L. Four days after the start of the diagnostic process, any rise in the serum hCG concentration makes the diagnosis of EP very likely.

Chorionic Gonadotropin↗
PubMed1998

Fertility after conservative and radical surgery for tubal pregnancy.

A retrospective cohort study was set up to evaluate the effectiveness of conservative and radical surgery for tubal pregnancy towards subsequent fertility. Consecutive patients undergoing conservative or radical surgery for tubal pregnancy between January 1990 and August 1993 in two university hospitals were included in the study. Outcome measures were spontaneous intrauterine pregnancy (IUP) and repeat ectopic pregnancy (EP). Of the 135 patients analysed, 56 underwent conservative surgery and 79 underwent radical surgery. Patients treated with conservative surgery achieved a higher 3-year cumulative pregnancy rate than those treated radically (P < 0.001, log-rank test). In patients treated conservatively, there was only one spontaneous IUP in the period between 18 months and 3 years after the tubal pregnancy. In contrast, patients treated radically continued to conceive in this period. Multivariate analysis showed a fecundity rate ratio (FRR) of 1.9 [95% confidence interval (CI): 0.91 to 3.8] for IUP after conservative surgery in the first 18 months of follow-up. In patients with a history of bilateral tubal disease the FRR was 3.1 (95% CI: 0.76 to 12), whereas in patients without a history of bilateral tubal disease the FRR was 1.4 (95% CI: 0.13 to 16). The FRR for repeat EP was 2.4 (95% CI: 0.57 to 11). Our data indicate a beneficial effect of conservative surgery towards subsequent fertility that was not, however, statistically significant in the multivariate analysis. In view of these inconclusive data and the importance of this major health problem, randomized studies are required to assess whether conservative surgery really improves the fertility prospects of patients with tubal pregnancy.

Adult↗
PubMed1997

Randomised trial of systemic methotrexate versus laparoscopic salpingostomy in tubal pregnancy.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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]). INTERPRETATION: 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.

Adult↗
PubMed1997

Diagnosis of ectopic pregnancy after in vitro fertilization and embryo transfer.

OBJECTIVE: The combination of transvaginal sonography and serum hCG measurement is reliable in the diagnosis of ectopic pregnancy (EP) in spontaneous pregnancies. In patients who became pregnant through IVF-ET, transfer of multiple embryos after IVF could be responsible for the different performance of these tests. We evaluated the discriminative capacity of transvaginal sonography in combination with hCG measurement in the diagnosis of EP after IVF-ET. DESIGN: Prospective cohort study. SETTING AND PATIENT(S): Consecutive patients, pregnant through IVF-ET, who presented with clinically suspected EP. INTERVENTION(S): Transvaginal sonography, serum hCG measurement at 6, 9, and 15 days after ET and after a negative transvaginal sonography. MAIN OUTCOME MEASURE(S): Ectopic pregnancy confirmed at laparoscopy. RESULT(S): Between September 1993 and May 1996, 86 women were included in the study, of whom 24 had an EP. Transvaginal sonography identified 46 intrauterine pregnancies and 5 EPs, but serum hCG could not diagnose EPs in patients in whom transvaginal sonography did not show a gestational sac. Serum hCG measurement 9 days after ET could identify pregnancy failure with 100% specificity at a cut-off value of 18 IU/L, but it could not identify patients with EP with enough certainty to justify immediate treatment. CONCLUSION(S): We recommend single serum hCG measurement 9 days after ET to discriminate between viable and nonviable pregnancies. Transvaginal sonography can be postponed until 5 weeks after ET, except for patients with abdominal pain and/or vaginal bleeding, or patients with a serum hCG level of < 18 IU/L.

Adult↗