Clinical observation on 184 cases of transvaginal cervical cerclage

doi:10.21203/rs.3.rs-3990831/v1

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Clinical observation on 184 cases of transvaginal cervical cerclage

https://doi.org/10.21203/rs.3.rs-3990831/v1

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Objective: To analyze the clinical characteristics and pregnancy outcomes of 184 pregnant women with cervical insufficiency (CI) who underwent transvaginal cervical cerclage (TVC) surgery, and to evaluate its effectiveness and clinical significance.

Method: A retrospective analysis was conducted on the case data of 184 pregnant women who underwent vaginal cervical cerclage from January 2017 to December 2023, including gestational age, gestational frequency, parity, cerclage time, cervical length before cerclage, extended gestational weeks after cerclage, pregnancy outcome, and newborn condition. Firstly, based on the cervical length at the time of cerclage, they were divided into a<2.0cm group (64 cases) and a ≥ 2.0cm group (83 cases); According to the timing of cervical cerclage surgery, 102 cases were divided into a scheduled group (including 44 cases of preventive cerclage and 58 cases of therapeutic cerclage) and an emergency group of 82 cases; The selective cervical cerclage group was divided into an early group (cervical cerclage performed at 9-16 weeks) of 44 cases and an advanced group (cervical cerclage performed at 16-24 weeks) of 45 cases based on the number of cycles of cerclage. The clinical characteristics of this disease were analyzed and summarized.

Result: The gestational age, extended gestational age, newborn body weight, and newborn Apgar score (1 and 5 minutes) of the group with cervical length ≥ 2.0cm during cerclage were significantly higher than those of the<2.0cm group, while the gestational age during cerclage was significantly lower than that of the<2.0cm group, with statistical significance (P<0.05 for all). There were statistically significant differences (P<0.05) in the cervical length during cerclage, gestational weeks during cerclage, extended gestational weeks, full-term delivery rate, newborn birth weight, 1-minute Apgar score, and 5-minute Apgar score between the prevention group and the emergency group of pregnant women. There was no statistically significant difference in the extended gestational week, delivery gestational week, delivery blood volume, newborn birth weight, fetal survival rate, cesarean section delivery rate, newborn 1-minute Apgar score, and newborn 5-minute Apgar score between the early group (12-16 weeks, 44 cases) and the late group (16-24 weeks, 55 cases).

Conclusion: Pregnant women with a cervical length of ≥ 2.0cm during cerclage have better pregnancy outcomes than those with a cervical length of<2.0cm; Preventive cervical cerclage can improve the rate of full-term delivery and fetal survival; Emergency cerclage is a feasible remedial measure; Transvaginal cervical cerclage at 16-25 weeks of pregnancy can be an effective method to prolong pregnancy time.

Despite advances in medicine over the past few decades, recurrent miscarriage, premature birth, and related complications remain a significant problem^[1]. Cervical insufficiency (CI) is a congenital or acquired anatomical structure or functional abnormality of the cervix, which leads to progressive and painless cervical shortening, dilation, and flattening before full-term pregnancy, making it difficult to maintain pregnancy until full-term. It generally occurs between 18–25 weeks of pregnancy, with an incidence rate of 0.1–1.0% of pregnancy. It is one of the main causes of late stage miscarriage and premature birth ^[2–4]. Cervical cerclage is currently the only surgical method and effective method for treating cervical insufficiency and preventing premature birth.

2.1 Materials

Collect case data of 184 pregnant women who underwent transvaginal cervical cerclage at Central South Hospital of Wuhan University from January 2017 to January 2023 due to cervical incompetence. The inclusion criteria for this study are: (1) meeting the diagnostic criteria for cervical insufficiency; (2) Perform cervical cerclage and delivery at our hospital. Exclusion criteria: Incomplete clinical data. The patients in this group are 23.0–40.0 years old, with a body mass index (BMI) of 18.0-33.6kg/m2 and 1–6 pregnancies. Among them, there were 5 cases of chorioamnionitis and 17 cases of assisted reproductive technology for pregnancy.

Diagnostic criteria for cervical incompetence ^{[3, 5]}: Using the diagnostic criteria of the American Association of Obstetricians and Gynecologists (ACOG) in 2014, cervical incompetence is considered a clinical diagnostic disease. Currently, clinical diagnosis is mainly based on the comprehensive medical history, typical clinical manifestations, and ultrasound examination results Having at least one or two instances of painless cervical dilation in early or late pregnancy, followed by no obvious uterine contractions, signs of labor, clear pathological factors such as bleeding, infection, rupture of membranes, and typical medical history of pregnancy discharge in mid pregnancy In the absence of uterine contractions, ultrasound measurement of cervical length during pregnancy is less than 2.5 cm; ③ Experimental diagnosis during non pregnancy: including iodinated oil imaging of the uterine cavity or fallopian tubes confirming tubular enlargement of the isthmus funnel area; The cervical opening can be measured using methods such as an 8th dilation strip and ultrasound to measure the width of the cervical canal at the level of the cervical opening, which is greater than 0.6cm.

Exclusion criteria: ① The fetal membrane has been ruptured; ② Prompt for intrauterine infection: body temperature ≥ 38 ° C: heart rate ≥ 100 beats/minute: WBC ≥ 15 × 10⁹L; Uterine tenderness; Vaginal discharge odor; ③ The fetus may have severe developmental abnormalities; ④ Pregnancy with severe internal and external diseases, unable to tolerate surgery.

2.2 Methods

Preoperative preparation: Communicate with patients and their families about the condition and inform them of the surgical risks, and sign an informed consent form for the surgery. Complete preoperative laboratory and obstetric related examinations.

Surgical procedure: Pregnant women underwent bladder lithotomy, and 184 cases of transvaginal cervical cerclage were performed using the McDonald procedure. There is no need to free the bladder during surgery, and purse string suture and cerclage are performed at the cervical vaginal junction.

Surgical management: Postoperatively, pregnant women are advised to rest in bed, reduce physical activity, and undergo 24-hour catheterization. Medication is given to suppress uterine contractions. Those with a history of infection or signs of infection are given symptomatic antibiotic treatment. Close observation of vital signs, uterine contractions, vaginal bleeding, vaginal discharge, vaginal secretions, etc.

Observation indicators: Pregnant woman's age, gestational frequency, parity, cervical length during cerclage, gestational week during cerclage, extended gestational week time, gestational week of delivery, delivery bleeding volume, newborn birth weight, cesarean section delivery rate, full-term delivery rate (including natural and cesarean sections), incidence of premature rupture of membranes, and fetal survival rate.

Statistical method: Using SPSS 22.0 statistical analysis software. Quantitative data is represented by x ± s and independent sample t-test is used; Count data is expressed in terms of examples (%), using x² test or Fisher's exact probability method. P < 0.05 indicates a statistically significant difference.

3.1 Grouping according to the length of the cervix during cerclage

The gestational age, extended gestational age, newborn body weight, and newborn Apgar score (1 and 5 minutes) of the group with a cervical length ≥ 2.0cm during cerclage were significantly higher than those of the < 2.0cm group, while the gestational age during cerclage was significantly lower than that of the < 2.0cm group, with statistical significance (P < 0.05); There was no statistically significant difference (P > 0.05) between the two groups in terms of age, number of pregnancies, IVF, and delivery bleeding, as shown in Tables 1 and 2.

Table 1

General information of patients
Group	<2.0cm	≥ 2.0cm	t/x2	P
Number of cases	64	83
Age	31.11 ± 4.32	31.42 ± 3.53	-0.482	0.63
Gravidity	3(2,3.75)	3(2,4)	-1.793	0.073
Parity	0(0,1)	0(0,1)	0.95	0.342
IVF	8(12.5)	9(10.84)	0.097	0.755

Table 2

Pregnancy outcome
Group	<2.0cm	≥ 2.0cm	t/x2	P
Number of cases	64	83
Cervical cerclage gestational weeks(week, x ± s)	21.68 ± 3.62	18.23 ± 4.08	5.328	< 0.001
Delivery gestational weeks(week, x ± s)	32.79 ± 5.22	36.07 ± 4.14	-4.253	< 0.001
Extend gestational weeks(week, x ± s)	11.11 ± 6.18	17.84 ± 5.49	-6.978	< 0.001
Newborn birth weight(g)	2065.08 ± 921.96	2722.72 ± 817.35	-4.574	< 0.001
Delivery bleeding volume(ml, x ± s)	331.2 ± 236.96	304.10 ± 123.82	0.898	0.371
Cervical length during cerclage(cm, x ± s)	1.01 ± 0.49	2.74 ± 0.67	-17.396	< 0.001
Newborn Apgar score(1min)	7.36 ± 2.45	8.25 ± 1.87	-2.413	0.017
Newborn Apgar score(5min)	8.50 ± 2.42	9.33 ± 1.95	-2.244	0.026
Neonatal survival [n(%)]	55(85.94)	80(96.39)	5.262	0.022
cesarean section [n(%)]	36(56.25)	54(65.06)	1.181	0.277
Full term delivery [n(%)]	20(31.25)	50(60.24)	12.176	< 0.001

3.2 Grouping according to the timing of cervical cerclage surgery

There were statistically significant differences (P < 0.05) in the cervical length during cerclage, gestational weeks during cerclage, extended gestational weeks, full-term delivery rate, newborn birth weight, 1-minute Apgar score, and 5-minute Apgar score between the prevention group and the emergency group of pregnant women; There was no statistically significant difference (P > 0.05) between the two groups in terms of age, parity, in vitro fertilization, neonatal survival rate, cesarean section delivery rate, and amount of bleeding during delivery (Tables 3 and 4).

Table 3

General information of patients
Group	prevention group	emergency group	t/x2	P
Number of cases	65	82
Age	31.37 ± 3.36	31.22 ± 4.27	0.231	0.817
Gravidity	3(2,4)	3(2,4)	-1.793	0.073
Parity	0(0,1)	0(0,1)	-0.824	0.41
IVF	6(9.23)	11(13.41)	0.621	0.431

Table 4

Pregnancy outcome
Group	prevention group	emergency group	t/x2	P
Number of cases	65	82
Cervical length during cerclage(cm, x ± s)	2.87 ± 0.68	1.29 ± 0.70	13.785	< 0.001
Cervical cerclage gestational weeks(week, x ± s)	17.65 ± 3.81	21.38 ± 3.83	-5.89	< 0.001
Extend gestational weeks(week, x ± s)	19.59 ± 4.39	11.21 ± 5.81	9.65	< 0.001
Delivery gestational weeks(week, x ± s)	37.23 ± 2.74	32.59 ± 5.28	6.44	< 0.001
Delivery bleeding volume(ml, x ± s)	296.15 ± 93.25	331.59 ± 228.23	-1.18	0.242
Neonatal survival [n(%)]	65(100)	68(82.92)	12.266	< 0.001
cesarean section [n(%)]	43(66.15)	47(57.31)	1.193	0.275
Full term delivery [n(%)]	48(73.85)	22(26.82)	32.13	< 0.001
Newborn birth weight(༈g, x ± s)	2935.15 ± 622.06	2041.05 ± 931.01	6.652	< 0.001
Newborn Apgar score(1min)	8.65 ± 0.93	6.50 ± 3.33	5.045	< 0.001
Newborn Apgar score(5min)	9.75 ± 0.64	7.50 ± 3.62	4.953	< 0.001

3.3 Grouping by cervical cerclage time

There was no statistically significant difference (P > 0.05) between the early group (14–16 weeks) and the late group (greater than 16 weeks but less than 18 weeks) in terms of extended gestational age, delivery gestational age, delivery blood volume, newborn birth weight, newborn 1-minute Apgar score, and newborn 5-minute Apgar score after cerclage, as shown in Table 5.

Table 5

Pregnancy outcome
Group	early group ((14–16 weeks))	late group (greater than 16 weeks but less than 18 weeks)	t	P
Number of cases	14	44
Extend gestational weeks(week, x ± s)	22.50 ± 4.06	19.44 ± 5.65	1.875	0.066
Delivery gestational weeks(week, x ± s)	36.14 ± 4.07	35.28 ± 5.60	0.527	0.6
Delivery bleeding volume(ml, x ± s)	267.86 ± 86.84	330.46 ± 163.02	-1.37	0.176
Newborn birth weight(༈g, x ± s)	2622.86 ± 735.78	2616.96 ± 1011.03	0.02	0.984
Newborn Apgar score(1min)	8.00 ± 2.45	7.72 ± 2.68	0.338	0.736
Newborn Apgar score(5min)	9.00 ± 2.63	8.77 ± 2.90	0.261	0.795

With the rapid development of medical technology, cervical cerclage surgery is gradually improving, but there is still a certain probability of adverse personal outcomes after surgery. In addition, the policy of having a second child for the elderly has been relaxed, and assisted reproductive technology has been widely used, increasing the number of elderly pregnant women. Therefore, pregnant women with cervical insufficiency are still at high risk of premature birth ^[6–8]. Cervical insufficiency is one of the main causes of late stage miscarriage and premature birth. At present, the main treatment for uterine insufficiency is cervical cerclage surgery, which is the only effective surgical treatment. Cervical cerclage surgery can be divided into transabdominal and cervical vaginal cerclage. The most commonly used surgical methods for transvaginal cervical cerclage are the McDonald and Shirodkar methods, typically performed at 12–14 weeks of pregnancy. The McDonald procedure only requires a purse string ligation at the cervical vaginal junction, with a simple surgical procedure that does not require incision of the anterior and posterior fornix or separation of the bladder and rectum. It has the advantages of low bleeding, short surgical time, and easy removal of sutures. In this study, 14 cases of 8 pregnant women underwent cervical cerclage using the McDonald procedure, which was successful with no significant adverse reactions during or after the surgery.

Multiple studies have reported that amniotic sac prolapse is a predictive factor for adverse pregnancy outcomes after emergency cerclage ^[9–11]. This study found that preoperative cervical length < 2cm is a related risk factor for adverse pregnancy outcomes after cerclage. Cervical cerclage can effectively restore cervical anatomical structure and physiological function, increase cervical tension, prevent cervical dilation, and enhance the weight-bearing capacity of the fetus and its appendages. Pregnant women with cervical canal shortening should actively intervene, strengthen prenatal testing, and reduce the incidence of premature birth.

This study shows that preventive cervical cerclage can effectively prolong gestational age, improve full-term delivery rate, newborn birth weight, newborn 1-minute Apgar score, and 5-minute Apgar score. Therefore, preventive treatment is appropriate for pregnant women with highly suspected or confirmed cervical insufficiency, which can obtain the best treatment opportunity, prolong gestational age, and improve pregnancy outcomes. Park H ^[12] Studies have shown that the timing of preventive cervical cerclage is relatively early and less stimulating to the cervix, which can reduce the risk of miscarriage caused by surgical stimulation. Research has shown ^[13] that emergency cerclage can reduce premature birth rates, prolong gestational age, and improve neonatal survival in patients with advanced cervical insufficiency, while not increasing the risk of chorioamnionitis and premature rupture of membranes.

This study is a retrospective study and cannot guarantee the completeness of all medical records. The selected subjects were all pregnant women who underwent cervical cerclage and gave birth in our hospital, and the pregnancy outcomes of pregnant women who gave birth in another hospital after cervical cerclage surgery were not followed up, which may lead to population bias. In future research, it is necessary to conduct prospective large-scale clinical randomized controlled trials in multi center medical institutions for further research.

Based on the data analysis of this study, pregnant women with a cervical length of ≥ 2.0cm during cerclage have better pregnancy outcomes than those with a cervical length of < 2.0cm; Preventive cervical cerclage can improve the rate of full-term delivery and fetal survival; Emergency cerclage is a feasible remedial measure; Transvaginal cervical cerclage at 16–25 weeks of pregnancy can be an effective method to prolong pregnancy time.

cervical insufficiency

TVC

transvaginal cervical cerclage

BMI

body mass index

ACOG

Association of Obstetricians and Gynecologists

Ethics approval and Consent to Participate

The experimental protocol was established, according to the ethical guidelines of the Helsinki Declaration and was approved by the Medical Ethics Committee, Zhongnan Hospital of Wuhan University. Written informed consent was obtained from individual or guardian participants.

Availability of Data and Materials

Data included in this study are openly and directly accessible within the manuscript and if any other material not displayed here is needed, it can be obtained upon formal and written request addressed to the main author ([email protected]).

Consent for Publication

Not applicable.

Funding

Not applicable.

Competing Interests

The authors declare that they have no competing interests.

Authors' Contribution

Min Zhou analyzed and interpreted the patient data regarding the transvaginal cervical cerclage. Huijun Chen performed the revision and inspection, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

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No competing interests reported.

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Clinical observation on 184 cases of transvaginal cervical cerclage

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Version 1

Abstract

1. Introduction

2. Materials and methods

2.1 Materials

2.2 Methods

3 Result

3.1 Grouping according to the length of the cervix during cerclage

3.2 Grouping according to the timing of cervical cerclage surgery

3.3 Grouping by cervical cerclage time

4 Discussion

5 Conclusion

Abbreviations

Declarations

References

Additional Declarations

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