Effectiveness of preconceptional preparation in women with early pregnancy loss

DOI

https://dx.doi.org/10.18565/aig.2020.1.83-92

Artymuk N.V., Noskova I.N., Tachkova O.A.
1) Kemerovo State Medical University, Kemerovo, Russia; 2) S.M. Belyaev Kemerovo Regional Hospital, Kemerovo, Russia

Objective. To evaluate the effectiveness of an integrated approach using intravaginal peloid therapy and oral dydrogesterone to improve an outcome in subsequent pregnancy in women with unexplained sporadic loss of early pregnancy.
Subjects and methods. A prospective, open-label, randomized study. Randomization was conducted using the envelope technique. The study enrolled 40 reproductive-aged women after sporadic pregnancy loss at less than 12 weeks of gestation. Group 1 consisted of 20 patients who, after spontaneous abortion, received peloid therapy using a gel based on Dead Sea mud. In the third menstrual cycle after abortion, the patients were prescribed 60 ml administered as a single intravaginal injection over 60 minutes for 12 days on days 7-8 of the menstrual cycle. If the period was delayed, a pregnancy test was carried out and when its results were positive, dydrogesterone was prescribed in a daily dose of 20 mg up to 20 weeks’ gestation. After spontaneous abortion, 20 patients in Group 2 underwent traditional rehabilitation, including physiotherapy and vitamin-mineral complexes. Primary and secondary outcomes were evaluated. The primary outcomes were the levels of estradiol (E2) and progesterone (PG), the frequency of ovulatory cycles, and that of recording the full secretory phase (histological examination of the endometrium on day 24 of the fourth menstrual period). The secondary outcomes were the rate of pregnancy during a year after completing rehabilitation, the frequency of recording heartbeats at 12 weeks of gestation, and the rate of live birth.All the patients underwent general clinical and special gynecological examinations. Enzyme immunoassay was used to measure the level of E2 on days 2-5 of the menstrual period and that of PG on days 21-22 of the second and fourth menstrual ones. A test was carried out to detect ovulation. All the patients underwent endometrial biopsy, followed by histological examination, on days 23-24 of the fourth menstrual period.
Results. All the patients enrolled in the study completed the planned protocol. The obtained results showed that there were no statistically significant differences in the levels of E2 and PG in the patients of the comparable groups (p>0.05). In the first menstrual period after a miscarriage, anovulation occurred in 15% and 42% of women, respectively; and the inadequate luteal phase (ILP) was observed in 55% and 42% (p=0.003). Three months after a miscarriage, anovulatory cycles were recorded in only the patients (39%) in Group 2 (p=0.008). Pipelle endometrial biopsy showed the presence of a full secretory phase and the correspondence of the endometrium to the phase of the cycle in 55.5% and 16.7% of patients, respectively (p=0.035); ILP in 38.9% and 61.1% and chronic endometritis in 16.7% and 55.5% (p=0.035). During a year after completion of rehabilitation, the occurrence of pregnancy was recorded in 17 (85%) women in Group 1 and in 8 (40%) patients in Group 2 (p=0.008). Fetal heart activity was recorded in all these women at 12 weeks’ gestation. There were 16 (80%) and 7 (35%) live births, respectively (p=0.01). The absolute benefit increase (ABI) when applying the integrated approach was 45%. The relative benefit increase (RBI) was 113%. That is, to achieve pregnancy in one woman with sporadic unexplained pregnancy loss within one year, it is necessary to treat two patients in this way. The odds ratio of the probability of obtaining a positive result in the use of peloid therapy versus traditional treatment was 8.50 [1.88-38.47].
Conclusion. Thus, the comprehensive approach including intravaginal peloid therapy at the preconceptional stage and administration of dydrogesterone, when pregnancies of less than 20 weeks’ gestation is recorded, is more effective than the traditional approach and can improve outcomes of subsequent pregnancy in patients with sporadic unexplained pregnancy loss. The combined use of peloid therapy and dydrogesterone contributes to the restoration of the biphasic cycle in patients with a history of early reproductive losses, to the creation of the full secretory phase, to the lower incidence of chronic endometritis, and allows a greater than twofold increase in live birth rates.

intravaginal peloid therapy

sporadic unexplained loss of pregnancy

oral dydrogesterone

Full text (in Russian)

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Received 27.08.2019

Accepted 04.10.2019

Natalya V. Artymuk, MD, professor, head of the Department of Obstetrics and Gynecology. prof. G. A. Ushakova Federal State Budgetary Educational Institution
of Higher Education Kemerovo State Medical University of the Ministry of Health of Russia. Tel .: +7 (960) 9233355. Email: artymuk @ gmail.com,
ORCID 0000-0001-7014-6492
650056, Russia, Kemerovo, ul. Voroshilova, d.22a.
Olga A. Tachkova, candidate of medical sciences, associate professor of the Department of Hospital Therapy and Clinical Pharmacology, Kemerovo State Medical University, Ministry of Health of Russia. Phone: + 7 (909) 5174932. E-mail: ol.an.t@yandex.ru, ORCID 0000-0002-6537-3460
650056, Russia, Kemerovo, ul. Voroshilova, d. 22a.
Irina N. Noskova, candidate of medical sciences, obstetrician-gynecologist, gynecological department, Kemerovo Regional Clinical Hospital named after S.M. Belyaev,
irnikno@yandex.ru, ORCID 0000-0002-1515-7233
650066, Russia, Kemerovo, Oktyabrsky prospekt, d. 22

For citation: Artymuk N.V., Noskova I.N., Tachkova O.A. Effectiveness of preconceptional preparation in women with early pregnancy loss.
Akusherstvo i Ginekologiya/ Obstetrics and gynecology. 2020; 1: 83-92. (In Russian).
https://dx.doi.org/10.18565/aig.2020.1.83-92

Effectiveness of preconceptional preparation in women with early pregnancy loss

Artymuk N.V., Noskova I.N., Tachkova O.A.

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