The evolution of oocyte donation in China

Objective

To review the experience with and clinical outcomes for recipients of embryos from oocytes donated under different regulatory standards in China. Initially, the oocytes were provided by one of the patient's consanguineous sisters. Then, the oocytes were obtained from another patient treated with assisted reproduction techniques (ART). Presently, oocytes thus produced are cryopreserved for at least 6 months before transfer.

Methods

The records from all women treated with ART at First Affiliated Hospital of Zhengzhou University since 2001 were reviewed and the pregnancy rates and clinical outcomes were determined for each of the 3 periods.

Results

In the second period, the mean implantation and clinical pregnancy rates were significantly higher for the 22 oocyte recipients than for their donors. In the third period, the rates for the 56 recipients were compared with the 78 other regular ART patients fertilized with their own oocytes. There were 40 live births for 32 of the recipients over 28 cycles, and the rates of implantation and clinical pregnancy were much higher for the recipients than for the other ART patients (P < 0.001).

Conclusion

Using freshly donated eggs yields a higher pregnancy rate but there is a risk of infectious disease. Using frozen oocytes can significantly decrease this risk but implantation rates are lower.     

A comparative study of the non-pneumatic anti-shock garment for the treatment of obstetric hemorrhage in Nigeria

Objective

To determine whether the non-pneumatic anti-shock garment (NASG) can improve maternal outcome.

Methods

Women were enrolled in a pre-intervention phase (n = 83) and an intervention phase (n = 86) at a referral facility in Katsina, Nigeria, from November 2006 to November 2007. Entry criteria were obstetric hemorrhage (≥ 750 mL) and a clinical sign of shock (systolic blood pressure < 100 mm Hg or pulse > 100 beats per minute). To determine differences in demographics, condition on study entry, treatment, and outcome, t tests and χ² tests were used. Relative risk (RR) and 95% confidence interval (CI) were estimated for the primary outcome, mortality.

Results

Mean measured blood loss in the intervention phase was 73.5 ±93.9 mL, compared with 340.4 ± 248.2 mL pre-intervention (P < 0.001). Maternal mortality was lower in the intervention phase than in the pre-intervention phase (7 [8.1%]) vs 21 [25.3%]) (RR 0.32; 95% CI, 0.14-0.72).

Conclusion

The NASG showed potential for reducing blood loss and maternal mortality caused by obstetric hemorrhage-related shock.     

Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial

Objective

To reevaluate the efficacy of induction of ovulation with CC versus TMX in a group of anovulatory subfertile women with PCOS in a randomized controlled trial.

Study design

A prospective randomized controlled study in which 371 PCOS patients were randomly allocated into two treatment groups: group A (187 patients) where women received CC and group B (184 patients) where they received Tamoxifen for one treatment cycle. The outcome measures were number of growing and mature follicles, serum E₂ (pg/ml), serum progesterone (ng/ml) and endometrial thickness, the occurrence of pregnancy and miscarriage.

Results

The number of stimulated follicles reaching ≥16 mm diameter was significantly more in the CC group compared to Tamoxifen stimulated group (2.1 SD ± 0.1 vs. 1.1 SD ± 0.7, p < 0.0001). The endometrium at the time of hCG administration was significantly thicker in the TMX group (10.1 ± 0.1 mm vs. 9.3 ± 0.4 mm, p < 0.0001). Ovulation occurred in 120/187 cycles (64%) in the CC group and 95/184 cycles (51.6%) in the TMX group with a significant difference between two groups in favors of clomiphene (p = 0.01). Serum E₂, on the day of hCG administration, was significantly higher in the clomiphene group (p < 0.0001). Pregnancy occurred in 35/187 cycles in group A (18.7%) and 20/184 cycles (10.8%) in group B and the difference was statistically significant (p = 0.04).

Conclusions

Clomiphene citrate is more successful than tamoxifen as a first line therapy for ovulation induction in women with PCOS.     

Change in the ovarian environment after hysterectomy as assessed by ovarian arterial blood flow indices and serum anti-Müllerian hormone levels

Objective

The aim of this prospective study was to evaluate the changes in the ovarian environment after hysterectomy based on ovarian arterial blood flow indices and serum anti-Müllerian hormone (AMH) levels.

Study design

Ovarian arterial blood flow indices (pulsatile and resistance indices) by Doppler ultrasonography and serum AMH levels were measured at baseline and 1 week, 1 month, and 3 months after hysterectomy in 32 women ranging in age from 38 to 49 years, or at the time of screening in 21 age-matched controls. The study subjects underwent hysterectomy with conservation of both ovaries for benign diseases of the uterus (laparoscopy-assisted vaginal hysterectomy [LAVH], n = 26; and total abdominal hysterectomy [TAH], n = 6). The study subjects and controls were analyzed using a t-test or one-way analysis of variance.

Results

No differences existed in demographic profiles, ovarian arterial blood flow indices, and serum AMH levels at baseline between the hysterectomy and control groups. Ovarian arterial blood flow indices did not change before and after surgery, and there were no serial changes in the mean levels of serum AMH at each time point (1.80 ± 1.81 ng/mL [pre-operatively], 1.69 ± 1.62 ng/mL [1 week post-hysterectomy], 1.42 ± 1.34 ng/mL [1 month post-hysterectomy], and 1.52 ± 1.72 ng/mL [3 months post-hysterectomy]; p = 0.805). In addition, no significant differences in ovarian arterial blood flow indices and serum AMH levels existed between the LAVH and TAH groups.

Conclusion

This preliminary study suggests that hysterectomy does not affect the ovarian environment for up to 3 months post-operatively, as assessed by ovarian arterial blood flow indices and serum AMH levels.     

Supraphysiological estrogen levels adversely impact proliferation and histone modification in human embryonic stem cells: possible implications for controlled ovarian hyperstimulation assisted pregnancy

Objective

Controlled ovarian hyperstimulation (COH) results in supraphysiologic levels of maternal serum estradiol (E₂) during the luteal phase, thus promoting oocyte production at unknown risk to the subsequently developing embryo. Human embryonic stem cells (hESCs) have been identified as a model system to assess the impact of COH on early embryonic development, specifically 17β-estradiol mediated effects on proliferation, gene expression, and histone modification.

Study design

Cell proliferation and associated factors, such as HDAC1, as well as histone modification patterns were evaluated in ERα and β expressing hESCs after exposure to 17β-estradiol (1 × 10⁻¹⁰ M to 1 × 10⁻⁷ M), as well as in an untreated control.

Results

Resultant data revealed that while physiologically relevant E₂ levels (1 × 10⁻⁹ M E₂) induced cell cycle progression from G1 to the proliferation phase, supraphysiologic levels akin to those observed after COH (1 × 10⁻⁷ M E₂) adversely affected hESCs proliferation via down regulation of HDAC1. Modification of H3K9me2, PhH3S10, H4K5ac, and H2A.Z histone patterns were also dependent on 17β-estradiol concentration.

Conclusion

While physiologic levels of 17β-estradiol induced cell proliferation, possibly via HDAC1 involvement in histone modification, cell proliferation in hESCs was suppressed at supraphysiologic levels.     

Comparison of saline infusion sonohysterography and hysteroscopy in diagnosis of premenopausal women with abnormal uterine bleeding

Objective

We aimed to study the effect of uterine arterial embolization (UAE) on the level of endometrial integrin ανβ3 in guinea pigs.

Study design

A total of 55 female guinea pigs were randomly divided into a sham group (n = 10) and a UAE group (n = 45). The animals in the UAE group were further divided into three subgroups, A1, A2 and A3, with 15 subjects in each subgroup. Bilateral UAE was performed in the UAE group by injection of 40-120 μm and 100-300 μm microspheres. Uterine tissue samples were collected three days after ovulation, i.e., one menstrual cycle after UAE for A1 group, two menstrual cycles after UAE for A2 group and three menstrual cycles after UAE for A3 group. Levels of endometrial integrin ανβ3 were tested by immunohistochemistry with mean optical density (MOD) analysis. Serum levels of estradiol and progesterone were measured before sample collection.

Results

The MOD values for integrin ανβ3 levels in endometrial glands were 0.393 ± 0.039, 0.253 ± 0.032, 0.319 ± 0.034, 0.365 ± 0.032 for the sham, A1, A2 and A3 groups respectively; in endometrial luminal epithelium they were 0.386 ± 0.036, 0.242 ± 0.035, 0.308 ± 0.042, 0.355 ± 0.031 for the sham, A1, A2 and A3 groups respectively. For both endometrial glands and luminal epithelium, ανβ3 levels in the sham group were statistically significantly higher than those in the A1, A2 and A3 groups (p₁ < 0.001, p₂ < 0.001, p₃ < 0.05); and they were significantly higher in the A2 group than in A1 group (p < 0.001), also in the A3 group than in A2 group (p < 0.001). The levels of estradiol and progesterone in blood serum both had no significant differences among the groups (p > 0.05).

Conclusions

UAE is associated with a decrease in endometrial integrin ανβ3 levels. The decrease would negatively affect endometrial receptivity, but might be transient and reversible.     

Transcatheter arterial chemoembolization versus systemic methotrexate for the management of cesarean scar pregnancy

Objective

To evaluate the effectiveness/safety of systemic methotrexate (MTX) treatment versus transcatheter arterial chemoembolization using different embolic agents for termination of cesarean scar pregnancy (CSP).

Methods

Women with CSP were randomized to receive intravenous infusion of MTX (group 1, n = 13), or chemoembolization with MTX and either gelatin sponge (GS; group 2, n = 15) or polyvinyl alcohol (PVA; group 3, n = 16) particles. Uterine suction curettage followed all procedures. Bleeding volume, time until resolution of serum β-hCG, and length of hospital stay were recorded as outcome endpoints.

Results

Bleeding volume was smaller in groups 2 (mean ± SD, 73 ± 20 mL) and 3 (63 ± 22 mL) than in group 1 (952 ± 471 mL) (P < 0.001). Time until resolution of β-hCG was shorter in groups 2 (29 ± 16 days) and 3 (30 ± 19 days) than in group 1 (57 ± 25 days) (P < 0.01). Length of hospital stay was shorter in groups 2 (13 ± 4 days) and 3 (12 ± 3 days) than in group 1 (36 ± 8 days) (P < 0.01).

Conclusion

Transcatheter arterial chemoembolization was more effective than systemic MTX treatment for termination of CSP. Large cohort studies are warranted to compare effectiveness between PVA and GS particles.     

Meperidine versus valethamate bromide in shortening the duration of active labor

Objective

To compare the efficacy and safety of meperidine hydrochloride and valethamate bromide against placebo in shortening the duration of active labor.

Method

We randomly assigned 160 nulliparous women with a singleton pregnancy at term who needed induction of labor to one of 3 treatments: 50 mg of meperidine (n = 53), 16 mg of valethamate bromide (n = 53), or a normal saline solution as placebo (n = 54). All medications were given by slow intravenous infusion. Labor duration was the main outcome measure.

Results

The intervals between infusion and complete cervical dilation and between infusion and delivery were significantly reduced (P < 0.001 and P < 0.01) in the meperidine group (103.0 ± 64.5 minutes and 119.8 ± 70.2 minutes), in contrast to the placebo group (173.9 ± 74.8 minutes and 192.2 ± 82.8 minutes). However, differences were not significant between the 2 treatment groups (139.6 ± 63.1 minutes and 160.6 ± 71.9 minutes), or between the valethamate bromide and the placebo group.

Conclusion

Meperidine, but not valethamate bromide, significantly shortened the duration of active labor in nulliparous women with a singleton pregnancy at term.     

Maternal serum protein S forms in pregnancies complicated by intrauterine growth restriction

Objectives

The clinical relevance of protein S deficiency in pregnant women remains controversial. Major debate exists regarding which parameter (total protein S antigen, free protein S antigen or functional protein S) should be evaluated in order to define protein S deficiency. The present study aimed to identify which of these parameters correlate with intrauterine growth restriction (IUGR).

Study design

A retrospective case-control study of women with IUGR (n = 27) and healthy controls (n = 123) in the third trimester of pregnancy.

Results

The maternal serum of women in the IUGR group had significantly lower levels of functional and free protein S compared with the control group: 54.07 ± 24.72% vs 65.20 ± 17.95% (p < 0.005) and 42.88 ± 11.01% vs 56.64 ± 13.30% (p < 0.0001), respectively. No significant correlation was found between total protein S and IUGR.

Conclusions

Levels of functional and free protein S are correlated with IUGR.     

Comparison of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor

Objective

To compare the efficacy and adverse effects of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor (AMTSL).

Methods

A double-blind randomized trial of 300 women with a healthy singleton pregnancy allocated into 4 groups to receive either: 400 µg or 600 µg of sublingual misoprostol, 5 IU of intravenous oxytocin, or 200 µg of intravenous methylergometrine. The primary outcome measure was blood loss in the third and fourth stage of labor; secondary measures were duration of the third stage of labor, changes in hemoglobin levels, and adverse effects.

Results

Patients who received 600 µg of misoprostol had the lowest blood loss (96.05 ± 21.1 mL), followed by 400 µg of misoprostol (126.24 ± 49.3 mL), oxytocin (154.7 ± 45.7 mL), and methylergometrine (223.4 ± 73.7 mL) (P < 0.01). Shortest mean duration of the third stage of labor (5.74 minutes) was with 600 µg of misoprostol, while methylergometrine had the longest (6.83 minutes) (P < 0.05). Pyrexia was observed in the misoprostol groups, and raised blood pressure in the methylergometrine group (P < 0.001). The 24-hour postpartum hemoglobin level was similar among the groups (P > 0.05).

Conclusion

Administration of 600 µg of sublingual misoprostol was more effective than 400 µg of misoprostol, intravenous oxytocin, and intravenous methylergometrine for AMTSL.     

Uterosacral-cardinal ligament stretching prior to vaginal hysterectomy increases uterine descent: a novel technique

Objective

To examine the effect of uterosacral-cardinal ligament complex stretching prior to vaginal hysterectomy on uterine descent.

Study design

A prospective trial of 25 consecutive women undergoing vaginal hysterectomy. Pre-operative, apical, anterior and posterior wall POP-Q measurements were recorded for each patient before and after uterosacral-cardinal ligament complex stretching during general anesthesia.

Results

Uterosacral-cardinal ligament complex stretching yielded a significant increase in mean stage of uterine and anterior wall descent (2.6 ± 0.6 vs. 3.2 ± 0.6 cm, p < 0.001, and 2.5 ± 0.8 vs. 2.9 ± 0.8 cm, respectively, p < 0.004). There was no significant change in posterior wall prolapse measurements (1.3 ± 0.7 vs. 1.4 ± 0.8 cm, p = 0.05).

Conclusion

Uterosacral-cardinal ligament complex stretching prior to vaginal hysterectomy increase uterine descent.     

Peripartum cardiomyopathy

Objective

To determine the clinical and echocardiographic profiles of women with peripartum cardiomyopathy and ascertain the natural course of the disease.

Methods

Fifty-six women with peripartum cardiomyopathy were followed up for a mean period of 6.1 years and their clinical and echocardiographic profiles were studied as well as their outcomes.

Results

The mean ± SD age at presentation was 31 ± 5 years and mean parity was 2.6 ± 1. Of the 56 patients, 18 (32.1%) had NYHA Class II, 24 (42.9%) had NYHA Class III, and 14 (25%) had NYHA Class IV symptoms, and 21 (37.5%) and 35 (62.5%), respectively, presented with features of heart failure during pregnancy and the postpartum. During follow-up, the left ventricular ejection fraction improved from 31% ± 7.2% to 43% ± 8% (P ≤ 0.05). Nine patients (16.1%) became pregnant, with a mortality of 55.5% during pregnancy and 23.2% during follow-up.

Conclusion

Women with peripartum cardiomyopathy present with severe left ventricular dysfunction late in the pregnancy or early in the puerperium. A considerable number of women still die from this condition despite the use of angiotensin-converting enzyme inhibitors and β-blockers. A subsequent pregnancy carries a very high risk of mortality.     

Reducing blood loss at abdominal myomectomy with preoperative use of dinoprostone intravaginal suppository: a randomized placebo-controlled pilot study

Objective

To determine the effect of a single preoperative intravaginal prostaglandin E₂ (PGE₂; dinoprostone) suppository on reducing intraoperative blood loss and the need for subsequent blood transfusion at abdominal myomectomy for symptomatic leiomyomas.

Study design

In a prospective randomized double-blind placebo-controlled pilot study, 108 women who had abdominal myomectomy for symptomatic leiomyomas were enrolled. Patients were randomly assigned to receive a single dose of intravaginal 20 mg dinoprostone (n = 54) or placebo (n = 54) 60 min before the operation. The primary outcome was the operative blood loss. The secondary outcomes were the need for blood transfusion, change in hemoglobin (Hb) level 24 h after operation, and the prevalence of side effects.

Results

Blood loss and transfusion rate were significantly greater in the group without PGE₂ suppository (group B) than in the group with PGE₂ (group A): they were respectively 485.7 ± 361.3 mL vs 364.1 ± 279.4 mL (P = .02; relative risk [RR] 0.95; 95% confidence interval [CI], 0.63–1.45) and 18.5% vs 3.7% (P = .04; RR 1.32; 95% CI, 3.7–18.5). Group B had a significant decrease in Hb level 24 h after operation compared with group A (P < .05). There was no difference in the patient demographics, intraoperative characteristics, postoperative stay, complications, and the side effects between the two groups.

Conclusion

A single pre-operative dose of dinoprostone administered intravaginally could be a safe and reliable method to help decrease blood loss during abdominal myomectomy. Further larger prospective studies are required to support this conclusion.     

Body Mass Index and spontaneous miscarriage

Objective

We compared the incidence of spontaneous miscarriage in women categorised as obese, based on a Body Mass Index (BMI) >29.9 kg/m², with women in other BMI categories.

Study design

In a prospective observational study conducted in a university teaching hospital, women were enrolled at their convenience in the first trimester after a sonogram confirmed an ongoing singleton pregnancy with fetal heart activity present. Maternal height and weight were measured digitally and BMI calculated. Maternal body composition was measured by advanced bioelectrical impedance analysis.

Results

In 1200 women, the overall miscarriage rate was 2.8% (n = 33). The mean gestational age at enrolment was 9.9 weeks. In the obese category (n = 217), the miscarriage rate was 2.3% compared with 3.3% in the overweight category (n = 329), and 2.3% in the normal BMI group (n = 621). There was no difference in the mean body composition parameters, particularly fat mass parameters, between those women who miscarried and those who did not.

Conclusions

In women with sonographic evidence of fetal heart activity in the first trimester, the rate of spontaneous miscarriage is low and is not increased in women with BMI > 29.9 kg/m² compared to women in the normal BMI category.     

Oral misoprostol reduces vaginal bleeding following surgical evacuation for first trimester spontaneous abortion

Objective

To assess the effectiveness and tolerability of misoprostol to reduce the amount and duration of vaginal bleeding following surgical evacuation for first trimester spontaneous abortion.

Methods

A total of 160 patients who underwent surgical evacuation for first trimester spontaneous abortion between 8 and 12 weeks of pregnancy were randomized into 2 groups to receive either 200 µg of oral misoprostol immediately after evacuation followed every 6 hours for 48 hours or no misoprostol. Pain scores, duration and amount of bleeding, and endometrial thickness were assessed over 10 days.

Results

Women who received misoprostol had significantly fewer bleeding days after evacuation (4.11 ± 2.69 vs 5.89 ± 3.06; P < 0.001), fewer patients reported vaginal bleeding lasting 10 days or more (3.8% vs 15.0%; P = 0.014), and endometrial thickness 10 days after evacuation was less (6.25 ± 2.38 vs 7.23 ± 1.94; P = 0.05). Pain scores were comparable in both groups (1.54 ± 0.65 vs 1.63 ± 0.83; P = 0.40) after 10 days.

Conclusion

Oral misoprostol is effective in reducing the prevalence and amount of vaginal bleeding after surgical evacuation for first trimester spontaneous abortion.     

Immunohistochemical expression of Annexin A2 and S100A proteins in patients with bulky stage IB-IIA cervical cancer treated with neoadjuvant chemotherapy

Objective

Abnormal expression of Annexin A2 and S100A proteins has been reported to induce sensitivity/resistance to chemotherapy in a variety of cancers. The aim of this study was to evaluate the significance of Annexin A2 and S100A protein expression to predict response to neoadjuvant chemotherapy and prognostic significance of these protein expressions in bulky stage IB-IIA cervical cancer patients.

Methods

Paired tumor samples (pre- and post-chemotherapy) were obtained from 68 patients who were treated with cisplatin-based neoadjuvant chemotherapy and radical hysterectomy at our hospital from 2006 to 2011. The expression of Annexin A2 and S100A proteins was analyzed by immunohistochemistry.

Results

Thirty-six patients were identified as chemotherapy-response and 32 were non-response. (a). Protein expression in tumor cells: (1). Exposure of tumor cells to chemotherapy results in a change of Annexin A2 and S100A expression (P < 0.05). (2). Annexin A2, S100A8 and S100A9 protein expression correlates with tumor response to chemotherapy (P < 0.05). (b). Protein expression in stromal cells: (1). Expression of Annexin A2, S100A8 and S100A9 was increased, but S100A2 and S100A4 was decreased after exposure to chemotherapy (P < 0.05). (2). Only S100A4 expression was associated with response to chemotherapy (P < 0.05). Multivariate analysis revealed that tumor size (P = 0.022), differentiation (P = 0.000), Annexin A2 expression in stromal cells (P = 0.009), and S100A8 expression in tumor cells (P = 0.008) were independent prognostic factors for progression-free survival of cervical cancer patients.

Conclusions

Expression of some of the measured proteins in tumor and stromal cells correlates with chemotherapy exposure, response to therapy, and progression-free survival.     

Human papillomavirus typing and soluble interleukin-2 receptor levels in female sex workers with a negative cervical smear result

Objective

To investigate the association between high-risk human papillomavirus (HPV) types and soluble interleukin-2 receptor (sIL-2R) levels in female sex workers with a negative cervical smear result, and to determine the effectiveness of using sIL-2R levels to screen for high-risk strains of HPV.

Method

A negative cervical smear result and a blood sample were obtained from 68 women: 43 female sex workers and 25 women acting as controls. HPV DNA genotyping was performed and sIL-2R levels were assessed.

Results

Female sex workers had significantly higher sIL-2R levels than women in the control group (318.37 ± 239.7 vs 114.4 ± 56.5 U/mL, respectively P < 0.001). In addition, female sex workers with high-risk strains of HPV had significantly higher sIL-2R levels than those who did not have high-risk strains of HPV (736.7 ± 251.5 vs 250.5 ± 156.1 U/mL, respectively; P = 0.001).

Conclusion

High sIL-2R levels may be useful in screening for high-risk strains of HPV in female sex workers who have a negative cervical smear result.     

Oxidized low-density lipoproteins in cord blood from neonates with intra-uterine growth restriction

Objective

We verified whether oxidative stress indices (oxidized low-density lipoproteins and malondialdehyde) and inflammatory biomarkers (circulating C-reactive protein, interleukin-6, tumour necrosis factor-α, serum amyloid A and soluble intercellular vascular cell adhesion molecule) are increased in the umbilical vein of placental insufficiency induced intra-uterine growth restricted neonates.

Study design

The prospective cohort study, involving 3 tertiary care centers, consists of 200 consecutively recruited pregnant women carrying twins. We chose the twin pregnancy model because both fetuses share the same maternal environment, thereby avoiding potential confounding factors when comparing oxidative stress and inflammation biomarkers. We analysed only twin pairs with one with intra-uterine growth restriction (N = 38) defined as fetal growth < 10th percentile with abnormal Doppler of the umbilical artery. Blood samples were taken at birth from the umbilical vein. Intra-pair comparisons on the biomarkers were performed using the Student paired t-test.

Results

We observed increased cord blood levels of oxidized low-density lipoproteins, (2.394 ± .412 vs 1.296 ± .204, p = .003) but not of malondialdehyde in growth restricted neonates when compared to their normal counterparts. Although indices of inflammation tended to be increased in cord blood from growth restricted newborns, the difference did not reach statistical significance.

Conclusion

In the twin model, intra-uterine growth restriction is associated with low-density lipoprotein oxidation without apparent dysregulation of inflammation biomarkers.

Condensation

Increased oxidized low-density lipoproteins are observed in growth restricted twins compared to their co-twins with normal growth at birth.     

Levator ani injury in primiparous women with forceps delivery for fetal distress, forceps for second stage arrest, and spontaneous delivery

Objective

To compare levator ani muscle injury rates in primiparous women who had a forceps delivery owing to fetal distress with women delivered by forceps for second stage arrest; and to compare these injury rates with a historical control group of women who delivered spontaneously.

Methods

Primiparous women who delivered by forceps were recruited retrospectively into 2 groups: forceps for fetal distress with short second stage (25 ± 11 minutes; n = 19); and forceps delivery for second stage arrest (137 ± 26 minutes; n = 19). MR images of the levator ani muscles were compared with a historical control group of women from a previous study who had delivered spontaneously (n = 129).

Results

Major defect rates were: 42% for forceps and short second stage; 63% for forceps and second stage arrest; and 6% for spontaneous delivery. The odds ratios for major injury were: 11.0 for forceps and short second stage compared with spontaneous delivery; 25.9 for forceps and second stage arrest compared with spontaneous delivery; and 2.3 for forceps and second stage arrest compared with short second stage (P = 0.07).

Conclusion

Women delivered by forceps have a higher rate of levator ani injury compared with spontaneous delivery controls; the difference between the forceps groups did not reach significance.     

Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study

Objective

To investigate the efficacy and safety of oral dienogest 2 mg compared with placebo in the treatment of endometriosis-associated pelvic pain (EAPP).

Study design

This was a 12-week, randomized, double-blind, placebo-controlled, multicenter (n = 33) study in Germany, Italy, and Ukraine of 198 women aged 18-45 years with laparoscopically confirmed endometriosis and EAPP score ≥30 mm on a visual analog scale (VAS). Dienogest 2 mg or placebo was administered orally once daily. The primary efficacy variable was absolute change in EAPP from baseline to Week 12, as determined by the target variables of change in VAS score and change in intake of supportive analgesic medication (ibuprofen) for pelvic pain.

Results

Mean reductions in VAS score between baseline and Week 12 in the full analysis set were 27.4 mm and 15.1 mm in the dienogest and placebo groups, respectively—a significant score difference of 12.3 mm in favor of dienogest (P < 0.0001). Changes in intake of supportive analgesic medication were modest in both groups. The primary efficacy measure of absolute change in EAPP demonstrated the superiority of dienogest over placebo. Dienogest was generally well tolerated and few adverse events were associated with therapy.

Conclusions

Dienogest at a dose of 2 mg daily for 12 weeks was significantly more effective than placebo for reducing EAPP.