Authored by Omima T Taha*
Abstract
Objective: To assess the immunomodulatory role of Dydrogesterone in preventing pregnancy loss in cases of threatened abortion.
Materials and methods: This were a prospective interventional study that included two groups each included 16 women. Group 1 included 16 pregnant women presented with symptoms of threatened abortion, and group 2 that included 16 health females with normal pregnancy. All of the studied females were subjected to complete clinical assessment. Laboratory assessment of serum levels of IL-4 (Marker of T-helper 2), IFN γ (Marker of T-helper 1) and serum progesterone level were done for all participants. All women in group 1 were treated with certain doses of Dydrogesterone while women in control group were not allowed to use any form of progesterone. Participants were assessed for IL-4, IFN-γ and progesterone after treatment. Also continuing pregnancy rates were calculated.
Results: Both groups were matched as regarding patients’ characteristics and baseline parameters. Dydrogesterone has resulted in significant decrease of Th1/Th2 ratio with shift from Th1 predominance to Th2 predominance. Continuing pregnancy rate in the threatened abortion group was 93.8%.
Conclusion: Dydrogesterone is useful in the treatment of threatened abortion via modulating cytokine profile and causing shift in Th1/Th2 ratio for Th2 predominance and more specifically via decreasing level of Th1 markers as IF-γ.
Keywords: Dydrogesterone; Immunomodulation; Pregnancy; Threatened abortion
Introduction
Women with threatened abortion present with vaginal bleeding and/or uterine cramps while the cervix is still closed. This critical state may end up in spontaneous abortion or pregnancy may continue normally [1]. Tolerance of the maternal immune system to paternally derived fetal antigens is mandatory for a successful pregnancy. Disturbed immunological response towards the growing embryo may lead to pregnancy failure [2].
Several theories have been developed. One of these hypotheses is Th1/Th2 shift. A shift from the pro-inflammatory T-helper 1 (Th1) cell-dependent cytokines i.e. tumor necrosis factor-α (TNF- α), interferon-γ (IFN- γ), interleukin (IL), IL-12, IL-18] to Th2-dependent anti-inflammatory cytokines (i.e. IL-3, IL-4, IL-5, IL-6, IL- 10, IL-13) seems to be typical for a successful pregnancy [2].
Shifting of the immune response towards the Th2 pattern would be of paramount benefit to the fetus, whereas dominance of pro-inflammatory Th1 cells may be hazardous. This hypothesis was supported by researches on different mouse strains with Leishmania infection during pregnancy, that lead to an anti-infectious Th1 response which was associated with failed implantation [3,4].
Progesterone has been proposed as a crucial immunomodulatory agent during early pregnancy, as it plays a role in the signaling chain of Th2-cell-dependent cytokines, and successful pregnancy is known to be a Th2-type phenomenon [4,5].
Dydrogesterone, an orally active progestogen, is similar to endogenous progesterone in its molecular structure and has a high affinity for progesterone receptors. It has the advantage of being devoid of androgenic side-effects in the mother (e.g. hirsutism, acne) or masculinizing effect on the female fetus [4,5]. The present study aimed to assess the immunomodulatory role of Dydrogesterone in preventing pregnancy loss in threatened.
Materials and Methods
After approval of our research ethics committee, this prospective interventional study was conducted in the obstetrics and gynecology department of Suez Canal University Hospitals from May 2017 to May 2019. The study was carried out among 32 pregnant females divided into two groups. Group 1 (study group) included 16 pregnant females who presented with symptoms of threatened abortion (bleeding, spotting and uterine cramps). Group 2 (control group) included 16 healthy females with normal healthy pregnancy with no symptoms of abortion and no history of habitual abortion as a reference group. Pregnant females with gestational age > 13 weeks, chronic medical disorders, genital tract anomalies, history of use of progesterone prior to or during the study, and females with history of hypersensitivity to Dydrogesterone were excluded from the study.
Methods
All of the studied patients were subjected to the following:
Thorough obstetric history taking with emphasis on:
• First day of the last menstrual period
• Obstetric history
• Symptoms of threatened abortion (bleeding, spotting, uterine cramps)
Complete general and obstetric examination:
• Vital signs
• Height, weight and BMI
• Per vaginal examination for assessment of the cervical state
Abdominal/vaginal ultrasound: This was performed to all patients to evaluate gestational age of the fetus, to exclude multiple pregnancies and to confirm viability of pregnancy.
Laboratory measurement:
• Routine laboratory assessment (CBC, Rh factor, and urine analysis).
• Maternal serum levels of IL-4 were determined as a marker of T-helper 2 cell activity and values of IFN-γ as a marker for T-helper 1 cell activity before and at the end of treatment in both groups. Serum IL-4 and IFN-γ levels were measured by enzyme- linked immunosorbent assay (ELISA) technique
• Serum progesterone was determined by enzyme immunosorbent assay (ELISA) before and after treatment
Treatment:
• Group 1 (Threatened abortion group) received Dydrogesterone 40mg (4 tablets) as an initial dose then 10mg tablets every eight hours until symptoms subside (at least one week after symptoms subside)
• Group 2 (control group) participants were not allowed to use any progestogens prior to or during the study. They received placebo daily until they reached 13 weeks gestation.
• Both groups received their regular antenatal care according to NICE clinical guidelines [6]
• Ethical approval: This study was carried out after obtaining ethical approval on 01/04/2017 with a research number 3467#.
Results
The two groups were matched as regard to age, special habits and consanguinity. There was no statistically significant difference between the studied groups as regard to gestational age, number of living children, parity and duration since last delivery (Table 1).
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