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The use of total cervical occlusion along with Mcdonald cerclage in patients with recurrent miscarriage or preterm deliveries.

Introduction

Recurrent miscarriage is a distressful condition and recurrent mid-trimester miscarriage in particular is disturbing to physician and patient alike, because the loss is that of a normal fetus in advancing stages of gestation. This form of miscarriage and preterm births appear to have similar etiologies, which include cervical weakness and/or ascending infection. (1,2,3,4,5)

Cervical weakness is often over-diagnosed as a cause of mid-trimester miscarriage. There is also no satisfactory objective test that can identify women with cervical weakness in the non-pregnant state. (6) Even though transvaginal ultrasound assessment of the cervix during pregnancy has been found to be useful in predicting preterm birth in some cases of suspected cervical weakness, (3) treatment of cervical incompetence with cervical cerclage may not actually result in improved perinatal survival. (7,8) Furthermore, meta analysis of trials on McDonald cerclage have failed to show a lower rate of preterm delivery before 28 and 34 weeks in women assigned to cervical cerclage. (4,6)

These body of evidence point to probably more than just cervical weakness as a cause of late trimester miscarriage and preterm births. (8-11) Ascending infection may be an important contributory factor to mid-trimester miscarriage and preterm delivery. (9-11) The evidence for this is the high frequency of finding organisms in the amniotic fluid which are also present in the vagina in patients with preterm labor. (11-13) Infection from the vagina may be as a result of loss of the protective cervical mucus plug (the operculum), which serves as an effective mechanical barrier between the vagina and the uterus and protects the feto-maternal unit from ascending infection during pregnancy. (14,15)

The essence of total cervical occlusion is to preserve the cervical mucus plug and prevent ascending infection and subsequent initiation of miscarriage and preterm birth. The use of cervical occlusion along with McDonald cerclage is presented in 26 patients in this study. Both procedures are simple and technically easy to perform.

Methods

This is a prospective observational study conducted over a period of twenty months on all patients presenting with recurrent mid-trimester miscarriage or delivery before 36 weeks to a private obstetric facility that serves as a referral center for obstetric and gynecologic cases in Kaduna Nigeria between 1st April 2008 and 31st December 2009. Patients with two previous miscarriages in mid-trimester or preterm delivery who had agreed to participate in the trial between 1st April 2008 and 31st December 2009 were included in the study. Patients had a history of two consecutive mid-trimester miscarriages or delivery before 36 weeks, and patients who have previously had a McDonald's or Shirodkar's cerclage with suboptimal results. This is defined as delivery before 36 weeks gestation despite the cerclage.

The inclusion criteria was as follows: 1) At least two previous mid-trimester miscarriages from diagnosed or suspected cervical weakness; 2) Failed McDonalds or Shirodkar's cerclage; 3) No medical complication in current pregnancy or previous pregnancies; 4) Singleton pregnancy with normal fetus on ultrasound scans; 5) Consent to participate in the study. While the exclusion criteria for this study included the following: 1) Vaginal discharge, ruptured or bulging membranes; 2) Medical disorder in current or previous pregnancy including HIV; 3) Bleeding in early pregnancy; and 4) Fetal anomaly.

Eligible patients had a transvaginal ultrasound scan done to confirm cervical length of less than 2.5 cm or internal OS diameter of 0.8 cm or more in the current pregnancy. A McDonald cerclage was performed with merselene tape under general anesthetic at the level of the internal cervical OS (as described by McDonalds), (16) and total external cervical OS occlusion was performed with nylon 2/0 or 3/0 ethicon suture on a curved needle between 13 and 16 weeks of gestation.

The cervical occlusion was placed transversely along the external cervical OS below the McDonalds suture to occlude external cervical OS using the anterior and posterior lips of the cervix with the nylon suture, (Fig. 1). The external cervical OS is totally occluded in continuous nylon suture starting from one end to the other. The suture was tied and left long enough to facilitate removal. Routine postoperative care using salbutamol and prophylactic antibiotics were given.

The patients were discharged as appropriate and routine antenatal care continued. At 37 weeks of gestation or with the onset of labor if earlier, both sutures were removed and the patients were allowed to deliver as appropriate. The maternal outcome in terms of infection, hemorrhage, trauma difficulty with removal or increased operative delivery and fetal outcome in terms of fetal weight and perinatal survival were observed and data is analyzed using simple frequency tables.

[FIGURE 1 OMITTED]

Results

Twenty-six patients who fulfilled the criteria were followed up to the time of delivery. The age range of the patients was 23 to 36 years with a mean age of 26.8 years. The patients have had fetal wastage of between two to eight with an average of four mid-trimester losses in the group. The profiles of the patients are presented in Tables 1 and 2.

Failed cervical cerclage in a previous pregnancy was observed in 6 out of 26 patients (23.8%). There were three patients who had more than one failed cervical cerclage, including one with three-failed cervical suture with subsequent fetal loss. However, there were no intra or postoperative complications in terms of hemorrhage, infection, or ruptured membranes. Though, one patient who was delivered by cesarean section presented with incompletely removed nylon suture two weeks after discharge.

In terms of the mode of delivery; 22 patients had normal vaginal delivery, while two patients had vacuum delivery and two had cesarean sections. The indications for the cesarean section were two previous cesarean sections in one patient, and poor progress in labor for the other patient. With regards to fetal outcome; 25 of the total 26 patients (96.2%) took their babies home. Overall, 24 (92.3%) patients delivered at term, while two patients delivered at 33 and 35 weeks respectively; one following spontaneous rupture of membranes at 33 weeks and the other with preterm labor at 35 weeks. The fetus delivered at thirty three weeks died after 48 hours from respiratory distress. This loss, 1 in 26 patients (3.8%) was the only fetal wastage observed, (Table 3). In this study, there was no extreme low birth weight as all the babies weighed greater than 1.5 kg. The baby delivered at 33 weeks weighed 1.9 kg. Over 80% of the patients had normal birth weight for the area of study.

[FIGURE 2 OMITTED]

[FIGURE 3 OMITTED]

Discussion

The use of early total cervical occlusion (ETCO) was introduced in 1980 but has not been popularized until of recent, when ten countries participated in a randomized controlled trial to evaluate its effectiveness. (17,18) In this study, which is a prospective observational study of 26 patients who had both McDonald cerclage and early total cervical occlusion; there was only one delivery at 33 weeks and eventual fetal loss. The success rate of 96.2% is superior to 89% observed from performing a trans-abdominal cerclage. (19,20) This is especially important if the simplicity of the procedure and the ability of the patients to achieve normal delivery are taken into consideration. The observed cesarean section rate of 7.7% is in keeping with normal rate for the unit of 10%.

Furthermore, 23.8% of the patients reported here had failed transvaginal cerclage in their previous pregnancies, but subsequently delivered at term following the addition of total cervical occlusion to McDonald cerclage. There was no significant postoperative morbidity observed in this study, which is similar to the findings observed in studies involving larger numbers of patients. (18) Also, cervical scarring was not observed in any of the patients. If other studies continue to support these results, then the role of retaining the cervical mucus plug in preventing mid-trimester pregnancy loss and preterm delivery will be not only be substantiated, but two simple vaginal procedures could be used to improve pregnancy outcome.

Conclusion

The addition of total cervical occlusion to transvaginal cerclage has improved fetal outcome in patients with recurrent pregnancy without increasing maternal morbidity or cesarean section rate.

DOI 10.5001/omj.2012.14

Acknowledgements

We acknowledge Dr. Dee Mc Cormack's instructions from Prof Secher who introduced us to this procedure (with illustrative diagram). No conflicts of interest to declare.

Received: 16 Oct 2011 /Accepted: 10 Dec 2011

References

(1.) Romero R, Espinoza J, Mazor M. Can endometrial infection/inflammation explain implantation failure, spontaneous abortion, and preterm birth after in vitro fertilization? Fertil Steril 2004 Oct;82(4):799-804.

(2.) Owen J, Yost N, Berghella V, Thom E, Swain M, Dildy GA III, et al; National Institute of Child Health and Human Development, Maternal-Fetal Medicine Units Network. Mid-trimester endovaginal sonography in women at high risk for spontaneous preterm birth. JAMA 2001 Sep;286(11):1340 1348.

(3.) Macdonald R, Smith P, Vyas S. Cervical incompetence: the use of transvaginal sonography to provide an objective diagnosis Utrasound. Obstet Gynecol 2001 Sep;18(3):211-216.

(4.) Althuisius SM, Dekker GA, van Geijn HP, Bekedam DJ, Hummel P. Cervical incompetence prevention randomized cerclage trial (CIPRACT): study design and preliminary results. Am J Obstet Gynecol 2000 Oct;183(4):823-829.

(5.) Rust OA, Atlas RO, Jones KJ, Benham BN, Balducci J. A randomized trial of cerclage versus no cerclage among patients with ultrasonographically detected second-trimester preterm dilatation of the internal os. Am J Obstet Gynecol 2000 Oct;183(4):830-835.

(6.) MRC/RCOG Working Party on Cervical Cerclage. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomised trial of cervical cerclage. Br J Obstet Gynaecol 1993 Jun;100(6):516-523.

(7.) Harger JH. Cerclage and cervical insufficiency: an evidence-based analysis. Obstet Gynecol 2002 Dec;100(6):1313-1327.

(8.) Rust OA, Atlas RO, Reed J, van Gaalen J, Balducci J. Revisiting the short cervix detected by transvaginal ultrasound in the second trimester: why cerclage therapy may not help. Am J Obstet Gynecol 2001 Nov;185(5):1098-1105.

(9.) Berghella V, Odibo AO, To MS, Rust OA, Althuisius SM. Cerclage for short cervix on ultrasonography: meta-analysis of trials using individual patient-level data. Obstet Gynecol 2005 Jul;106(1):181-189.

(10.) Althuisius S, Dekker G. Controversies regarding cervical incompetence, short cervix, and the need for cerclage. Clin Perinatol 2004 Dec;31(4):695 720, v-vi.

(11.) Minkoff H. Prematurity: infection as an etiologic factor. Obstet Gynecol 1983 Aug;62(2):137-144.

(12.) Romero R, Mazor M, Wu YK, Sirtori M, Oyarzun E, Mitchell MD, et al. Infection in the pathogenesis of preterm labor. Semin Perinatol 1988 Oct;12(4):262-279.

(13.) Romero R, Sirtori M, Oyarzun E, Avila C, Mazor M, Callahan R, et al. Infection and labor. V. Prevalence, microbiology, and clinical significance of intraamniotic infection in women with preterm labor and intact membranes. Am J Obstet Gynecol 1989 Sep;161(3):817-824.

(14.) Cassell GH, Davis RO, Waites KB, Brown MB, Marriott PA, Stagno S, et al. Isolation of Mycoplasma hominis and Ureaplasma urealyticum from amniotic fluid at 16-20 weeks of gestation: potential effect on outcome of pregnancy. Sex Transm Dis 1983 Oct-Dec;10(4)(Suppl):294-302.

(15.) Gray DJ, Robinson HB, Malone J, Thomson RB Jr. Adverse outcome in pregnancy following amniotic fluid isolation of Ureaplasma urealyticum. Prenat Diagn 1992 Feb;12(2):111-117.

(16.) Secher NJ, McCormack CD, Weber T, Hein M, Helmig RB. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion. BJOG 2007 May;114(5):1-6 .

(17.) Hein M, Valore EV, Helmig RB, Uldbjerg N, Ganz T. Antimicrobial factors in the cervical mucus plug. Am J Obstet Gynecol 2002 Jul;187(1):137-144.

(18.) McDonald, I. A.: Suture of the cervix for inevitable miscarriage. J. Obstet. & Gynaecol. Brit. C'wlth., 1957, 64:346-350.

(19.) Saling E , Schumacher E. Total surgical cervical occlusion. Conclusions from data of several clinica, which use total surgical cervical occlusion. Z Geburtshilfe Neonatol 1996 May-Jun;200(3):82-87.

(20.) Saling E, Schumacher E. Results of follow-up of mothers with previous surgical "total cervical cerclage" also with reference to neonatal data Geburtshilfe Neonatol. Jul-1997 Aug; 201(4):122-7.

Marliyya Zayyan [mail]

Department of Obstetrics and Gynecology Ahmadu Bello University Teaching Hospital Zaria.

E-mail: marzayyan@yahoo.com

Sanusi R. Suhyb

Department of Surgery, Ahmadu Bello University Teaching Hospital Zaria.

Nwaorga O'C laurel

Diamond Specialist Hospital Kaduna. Nigeria.
Table 1: Age of Patients with Recurrent Miscarriage.

Age of             No of
Patients (years)   Patients (%)         Percentage

21-25              4                    15.4
26-30              15                   57.7
31-35              4                    15.4
36-40              3                    11.5
Total              26                   100

Table 2: Number of Miscarriages Experienced by the Patients.

                No. of
Number of       Miscarriages in
miscarriages    Patients          Percentage

2-3             5                 19.2
4-5             13                50.0
6-7             6                 23.1
8+              2                 7.7
Total           26                100.0
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Title Annotation:Brief Communication
Author:Zayyan, Marliyya; Suhyb, Sanusi R.; O'C Laurel, Nwaorga
Publication:Oman Medical Journal
Article Type:Report
Date:Jan 1, 2012
Words:2142
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