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Chinese to English: Effect and risk analysis of misoprostol in stimulating cervical maturity for post-term pregnancy General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Chinese 妊娠满41周到不满42 周之间称廷期妊娠，此期是由足月妊娠向过期妊娠发展的过渡阶段。有关研究表明； 廷期妊娠并发羊水过少的几率高， 新生儿Apgar 评分渐减, 手术产率显著增高，故应视其为高危妊娠[1]。 本研究探过廷期妊娠低宫颈 Bishop 评分（以下简称Bishop评分）伴宫颈分泌物胰岛素样生长因子给合蛋白-1 （IGFBP-1）阴性孕妇，使用来索前例醇（以下简称米索）促宫颈成熟的效果与风险。
Translation - English Pregnancies between the end of week 41 and into week 42 are called post-term pregnancies, this period is an interim period where full-term pregnancy and development has gone over the normal time period.
Relevant research indicates that the probability of less amniotic fluid being present in post-term pregnancy is greater; the Apgar score of newborns gradually decreases; the need for surgery during birth is significantly greater and the reason for this is that the pregnancy is in danger[1]. This research has investigated the lowering of the cervical Bishop score (hereafter referred to as Bishop score) in post-term pregnancies and will evaluate the effect and risk of misoprostol for stimulating cervical maturity in women with post-term pregnancy negative for insulin-like growth factor binding protein-1 (IGFBP-1) in cervical secretion.
1. Objective and Method
1.1 Research aims
Between May 2000 and June 2005 I saw 351 cases of post-term pregnancy at the obstetrics department of the hospital – of those 103 cases had a Bishop score of ≤ 3. Seventy-one cases who met the following criteria were selected for research purposes:
1. Those pregnant with their first and only child, the position of the fetus' head, the fetal membrane in-tact, no uterine contractions.
2. Regular menstrual cycle, response to pregnancy, movement of the fetus appears to be normal.
3. The colour Doppler ultrasound scan has eliminated any instance of macrosomia, amniotic fluid is overly reduced, the placenta has aged and fetal bio-physical score is low.
4. Urinary estriol/creatinine ratio(E / C) is normal.
5. NST non-stress test (NST) ≥ 8.
6. Head-basin score ≥ 8.
7. No serious pregnancy complications.
8. No glaucoma, asthma, epilepsy induced labour or misoprostol allergy contraindications.
9. IGFBP-1 negative.
Pragmatically divided into two groups: misoprostol group – 37 cases (observation group) and oxytocin drip group – 34 cases (control group). The ages of the mother, the pregnancy term and the difference in newborn birth-weights across the two groups was not significant.（P>0.05).
1.2 Method
1.2.1 The Bishop score was taken at the same time by two experienced physicians according to the modified Bishop score method, the mean value was taken once every 24 hrs. Changes in the Bishop score - before and after medication was taken - are compared, changes in cervical maturity among two groups were noted.
1.2.2 Treatment methods: After a routine sterilization of the outside of the vagina in Observation Group patients, the cervix is exposed using the vaginal speculum, secretion is wiped clean using a cotton ball, and the vaginal speculum is removed after 25 µg misoprostol is placed at the posterior vaginal fomix. The patient should lay down for 60 minutes. In the Control Group oxytocin drip is administered as routine to stimulate cervical maturity. If cervical maturity isn't reached 24 h after administering misoprostol and oxytocin, then repeat at a dose of once every 24h, not exceeding 3 times. If labour has not been induced after 72 h or the Bishop score is less than 7, opt for a cesarean section to end the pregnancy.
1.2.3 IGFBP-1 evaluation method and judgement on conclusion: Reagent kits were manufactured by the Shanghai Keane Technology Co. Ltd, Immunohistochemical determination of chromatography. Pregnant woman to take lithotomy position, standard sterilisation of outer vagina, speculum used to reveal cervix. Place the woollen swab from the reagent kit centrally inside the neck of the cervix for 15 seconds and then remove, immediately place into a test-tube containing 0.5ml soluble liquid for at least 30 seconds, and, spin the tip of the test-tube as much as possible so as to separate out the liquid substance from the swab. Remove swab retaining the soluble liquid, and place liquid on the yellow immersion area on the strips provided with the reagent kit and hold for approx. 20 seconds or until the liquid has permeated the reactive area – place on a level surface and examine results within 5 minutes. Result: The presence of two blue lines on the strip indicates a positive response, one blue line means negative. The absence of any blue line means that the structure was ineffective.
1.2.4 Other details of observation: General circumstances of the expectant mothers, including foetal heart; foetal movement; birth signs; reactions to medication, etc., electronic fetal heart monitoring once daily. Record when the pregnancy is due; the status of contractions; delivery method; nature of amniotic fluid; amount of blood loss after giving birth as well as newborn Apgar score. Before medication and after delivery examine bloods; normal circumstance around urination; time that blood clotting occurs; electrocardiogram and kidney and liver function.
1.2.5 Judgement on results of stimulating cervical maturity and effect produced when Bishop score increases ≥ 3. An increase of 1-2 points is effective; score does not become ineffective. Overall rate of effectiveness: results were shown and there was an effect. With a Bishop score of ≥ 7, there was cervical maturity. [2].
1.3 Dealing with statistics
All data used, on average, EP16 to input. SAS6.12 software package is in the process of being developed; measurement data use a mean ± standard deviation; calculations expressed as a percentage. Method of calculation: precise probability method, χ² test and t test. P
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