ABSTRACT
We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl estradiol (EE) and 0.075 mg of gestodene (GS) in ovulation inhibition and inducing unfavorable cervical mucus changes using a delayed-starting approach. This randomized controlled trial involved 36 participants aged 18-45 years. The major outcomes included ovulation inhibition assessed using the Hoogland and Skouby score, and cervical mucus permeability, assessed using the modified World Health Organization score. The results demonstrated ovulation inhibition rates of 77.8% for the EE/GS group and 88.9% for the DRSP group. The risk ratio and absolute risk reduction were 0.50 (95% confidence interval [CI]: 0.10, 2.40) and - 0.11 (95% CI: - 0.35, 0.13), respectively, satisfying the 20% non-inferiority margin threshold. The median time to achieve unfavorable cervical mucus changes was comparable between the DRSP (3 days, interquartile range [IQR]: 6 days) and EE/GS (3.5 days, IQR: 4 days) groups. However, the DRSP group had a higher incidence of unscheduled vaginal bleeding (55.56% vs. 11.11%; p = 0.005). DRSP-only pills, initiated on days 7-9 of the menstrual cycle, were non-inferior to EE/GS pills in ovulation inhibition. However, they exhibited delayed unfavorable cervical mucus changes compared to the standard two-day backup recommendation.Clinical trial registration: Thai Clinical Trials Registry (TCTR20220819001) https://www.thaiclinicaltrials.org/show/TCTR20220819001 .
Subject(s)
Androstenes , Contraceptives, Oral, Combined , Ethinyl Estradiol , Ovulation Inhibition , Humans , Female , Adult , Ethinyl Estradiol/administration & dosage , Androstenes/administration & dosage , Androstenes/adverse effects , Young Adult , Adolescent , Contraceptives, Oral, Combined/administration & dosage , Ovulation Inhibition/drug effects , Single-Blind Method , Middle Aged , Norpregnenes/administration & dosage , Norpregnenes/adverse effects , Ovulation/drug effects , Cervix Mucus/drug effectsABSTRACT
OBJECTIVE: To determine the correlation between serum placental growth factor (PlGF) and human chorionic gonadotropin (hCG) in patients with gestational trophoblastic disease (GTD) and to compare serum levels of PlGF in patients with gestational trophoblastic neoplasia to those of patients with hydatidiform mole. STUDY DESIGN: Blood and urine samples were collected from GTD patients. Blood and urine levels for PlGF were processed and quantitated by enzyme-linked immunosorbent assay in parallel with serum levels for hCG. Correlation levels of serum PlGF and hCG were analyzed. Serum levels of PlGF and hCG were correlated with the clinical manifestations of GTD. RESULTS: The correlation between serum levels of PlGF and hCG was not linear (r = 0.274, p = 0.229). The median PlGF levels in benign and malignant groups were 24.0 and 38.3 pg/mL, respectively (p = 0.014). The median serum hCG levels in benign and malignant groups were 7,335.0 and 9,974.5 mlU/mL, respectively (p = 0.942). The linear correlation between urine and serum levels for PlGF was not detected (r = 0.064). CONCLUSION: Levels of correlation for serum PlGF and hCG in GTD patients were not linear. Median serum levels of PlGF between benign and malignant groups were significantly different. This suggests that there is a higher production of PlGF levels in patients with choriocarcinoma or malignant GTD.
