Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.

Abstract:

OBJECTIVE:To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection. METHODS:In an open-label noninferiority randomized trial, pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) were randomly assigned to balloon catheter that was placed either digitally or using a sterile speculum. The primary outcome was a composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife). Prespecified secondary outcomes included outcomes in the primary composite, cesarean delivery rates, and maternal and neonatal outcomes. A patient satisfaction survey was also obtained. On the basis of a noninferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm noninferiority with 90% protocol adherence). RESULTS:From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum). Baseline characteristics were similar between groups. The composite maternal infection rate was not different between groups (digital placement arm: 15.7% vs speculum arm: 12.8%), with an absolute difference with respect to the sterile speculum arm of 2.8% (95% CI -4.3 to 9.9%), indicating noninferiority for the prespecified margin. Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm. Maternal and neonatal adverse events were not different between groups. Irrespective of method of placement, women were equally satisfied with the explanation of the method before placement, anxiety regarding the procedure, and pain during placement. More women in the sterile speculum group would choose the digital placement method for the subsequent pregnancy (37.6% vs 25.7%; P=.02.). CONCLUSION:Digital placement of a balloon catheter for preinduction cervical ripening is noninferior to the sterile speculum method, in terms of maternal infection. Women in the sterile speculum group more frequently required a second round of the mechanical dilator. The blind digital approach is a reasonable option for balloon placement for cervical ripening. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT03450408.

journal_name

Obstet Gynecol

authors

Kuhlmann MJ,Spencer N,Garcia-Jasso C,Singh P,Abdelwahab M,Vaughn M,Marshall K,Prasad N,Soulsby-Monroy R,Saade GR,Saad AF

doi

10.1097/AOG.0000000000004182

subject

Has Abstract

pub_date

2021-01-01 00:00:00

pages

139-145

issue

1

eissn

0029-7844

issn

1873-233X

pii

00006250-202101000-00018

journal_volume

137

pub_type

杂志文章
  • Chronic pelvic pain and previous sexual abuse.

    abstract:OBJECTIVE:To determine whether there is an association between history of sexual abuse and development of chronic pelvic pain. METHODS:We studied 36 women with chronic pelvic pain, 23 with chronic low back pain, and 20 healthy women with reference to experience of sexual abuse, physical violence, and emotional neglect...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(00)01072-3

    authors: Lampe A,Sölder E,Ennemoser A,Schubert C,Rumpold G,Söllner W

    更新日期:2000-12-01 00:00:00

  • Experience with midtrimester abortion.

    abstract::The midtrimester abortion program at a large community hospital was evaluated. During the 3-year study, 1839 patients aborted in the midtrimester by intraamniotic injection of hypertonic saline, prostaglandin F2alpha or a combination of saline and prostaglandin F2alpha. The method, using a combination of saline and pr...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Pahl IR,Lundy LE

    更新日期:1979-05-01 00:00:00

  • Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial.

    abstract:OBJECTIVE:Maternal anal sphincter tears after vaginal delivery are frequently not diagnosed clinically and are associated with subsequent fecal incontinence. This study examined whether diagnosis of these tears by ultrasonography, followed by immediate surgical repair, reduces the occurrence of incontinence. METHODS:W...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/01.AOG.0000165273.68486.95

    authors: Faltin DL,Boulvain M,Floris LA,Irion O

    更新日期:2005-07-01 00:00:00

  • Association of E. coli sepsis in pregnancy with a CU-7 intrauterine device in place.

    abstract::Several reports of pregnancy and sepsis associated with an intrauterine device have been reported. A case of a CU-7 in utero with sepsis due to Escherichia coli in a 10-12 week gestation is presented. ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Propper NS,Moore JH

    更新日期:1976-07-01 00:00:00

  • Placental changes in gestational diabetes. An ultrastructural study.

    abstract::A light microscopic, an electron microscopic, and a ultrahistochemical study have been made of seven placentas from women with mild and excellently controlled chemical gestational diabetes. Only one placenta showed no significant abnormality; the remainder showed, to a varying degree, changes in the syncytiotrophoblas...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Jones CJ,Fox H

    更新日期:1976-09-01 00:00:00

  • Risk factors associated with presenting for abortion in the second trimester.

    abstract:OBJECTIVE:To determine factors associated with delay of induced abortion into the second trimester of pregnancy. METHODS:Using audio computer-assisted self-interviewing, 398 women from 5 to 23 weeks of gestation at an urban hospital described steps and reasons that could have led to a delayed abortion. Multivariable l...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/01.AOG.0000189095.32382.d0

    authors: Drey EA,Foster DG,Jackson RA,Lee SJ,Cardenas LH,Darney PD

    更新日期:2006-01-01 00:00:00

  • Occurrence and predictors of cesarean delivery for the second twin after vaginal delivery of the first twin.

    abstract:OBJECTIVE:To estimate the occurrence and to assess clinical predictors of emergent cesarean delivery in the second twin after vaginal delivery of the first twin. METHODS:We conducted a population-based cohort study, using the 1995-1997 linked mother/infant twin data from the United States. The adjusted risk ratios and...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/01.AOG.0000110248.32558.fb

    authors: Wen SW,Fung KF,Oppenheimer L,Demissie K,Yang Q,Walker M

    更新日期:2004-03-01 00:00:00

  • Complications and risk factors associated with the removal of Norplant implants.

    abstract:OBJECTIVE:To describe the complications reported at the removal of Norplant implants, and to suggest potential risk factors for these complications. METHODS:Complications at the removal of Norplant implants from 3416 users from 11 countries who participated in preintroductory clinical trials of the method were tabulat...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/0029-7844(94)00458-P

    authors: Dunson TR,Amatya RN,Krueger SL

    更新日期:1995-04-01 00:00:00

  • Umbilical artery regression: a rare complication of intravascular fetal transfusion.

    abstract:BACKGROUND:Intravascular fetal transfusion is an important therapeutic advance but is associated with several complications. Regression of an umbilical artery associated with transfusion is rare. CASE:A case of red blood cell alloimmunization managed by serial transfusions was complicated by functional loss of an umbi...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(98)00502-x

    authors: Smith JF Jr,Warner KD,Bergmann M,Pushchak MJ

    更新日期:1999-05-01 00:00:00

  • Contraction stress test by intermittent nipple stimulation.

    abstract::Although the nonstress test has generally supplanted the contraction stress test as the primary test for assessment of fetal well-being, the contraction stress test continues to be useful. Objectionable factors of the contraction stress test have included the time required to complete the test and the frequent necessi...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Huddleston JF,Sutliff G,Robinson D

    更新日期:1984-05-01 00:00:00

  • Prognostic importance of intraoperative rupture of malignant ovarian epithelial neoplasms.

    abstract:OBJECTIVE:To determine whether rupture of malignant ovarian epithelial tumors at the time of operation influences the patient's overall prognosis. METHODS:Between 1975 and 1990, 79 patients with stage I invasive epithelial ovarian cancer were treated at Massachusetts General Hospital. Patients were identified from the...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Sainz de la Cuesta R,Goff BA,Fuller AF Jr,Nikrui N,Eichhorn JH,Rice LW

    更新日期:1994-07-01 00:00:00

  • Interleukin-6 and antiphospholipid antibodies in women with contraceptive-related thromboembolic disease.

    abstract:OBJECTIVE:The aim of this study was to explore the possible (joint) contributing role of interleukin-6 (IL-6) and antiphospholipid antibodies to the occurrence of the venous thromboembolism in women using oral contraceptives. METHODS:Interleukin-6 and antiphospholipid antibodies (anti-beta2-glycoprotein I antibody-imm...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/01.AOG.0000136083.13544.02

    authors: Salobir B,Sabovic M

    更新日期:2004-09-01 00:00:00

  • Vacuum-assisted closure in the treatment of complex gynecologic wound failures.

    abstract:BACKGROUND:Complex wound failures are a source of significant morbidity and mortality. They are costly and time consuming to treat, and may evolve into chronic, debilitating conditions. Vacuum-assisted closure is a novel wound healing technique applying subatmospheric pressure to wounds to expedite healing. CASES:We r...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(01)01752-5

    authors: Argenta PA,Rahaman J,Gretz HF 3rd,Nezhat F,Cohen CJ

    更新日期:2002-03-01 00:00:00

  • Brenner tumor and mucinous cystadenoma of borderline malignancy in a patient with Turner's syndrome.

    abstract::A 64-year-old woman with a 45,X karyotype and Turner's syndrome and recent onset of right lower quadrant pain was found to have a mucinous cystadenoma with focal areas of borderline malignancy and a typical Brenner tumor in the right adnexa. Ovarian tumors in patients with a 45,X karyotype and Turner's syndrome are ex...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Murphy GF,Welch WR,Urcuyo R

    更新日期:1979-11-01 00:00:00

  • Effect of type of anesthesia on blood loss at cesarean section.

    abstract::Halogenated anesthetic agents have been used to supplement nitrous oxide during balanced general anesthesia for cesarean delivery to decrease maternal awareness. However, these agents can interfere with uterine contractility and hence have the potential to increase blood loss at the time of cesarean section. To ascert...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Gilstrap LC 3rd,Hauth JC,Hankins GD,Patterson AR

    更新日期:1987-03-01 00:00:00

  • Foot necrosis in a surviving fetus associated with twin-twin transfusion syndrome and monochorionic placenta.

    abstract::Twin gestations with diamniotic monochorionic placentas have increased perinatal morbidity. We report a case in which, following the death of one member of a set of twins, absent end-diastolic flow was noted. At delivery, we noted thrombosis of placental vessels and vascular connections between the placental vessels o...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Margono F,Feinkind L,Minkoff HL

    更新日期:1992-05-01 00:00:00

  • A randomized trial of extra-amniotic saline infusion plus intracervical Foley catheter balloon versus prostaglandin E2 vaginal gel for ripening the cervix and inducing labor in patients with unfavorable cervices.

    abstract:OBJECTIVE:To compare the efficacy of extra-amniotic saline solution infusion plus an intracervical Foley catheter balloon versus 2.85 mg prostaglandin (PG) E2 vaginal gel in ripening the cervix, inducing labor, and achieving vaginal delivery in patients at term with an unfavorable cervix. METHODS:A randomized study of...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Rouben D,Arias F

    更新日期:1993-08-01 00:00:00

  • Postoperative pain after local anesthetics for laparoscopic sterilization.

    abstract:OBJECTIVE:To test the effectiveness of intraperitoneal local anesthesia in relieving postoperative pain after laparoscopic sterilization. METHODS:In a double-blind, placebo-controlled randomized study of two groups of 25 subjects each, women scheduled for tubal sterilization under general anesthesia received 80 mL of ...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Benhamou D,Narchi P,Mazoit JX,Fernandez H

    更新日期:1994-11-01 00:00:00

  • Fetal injury associated with cesarean delivery.

    abstract:OBJECTIVE:To describe the incidence and type of fetal injury identified in women undergoing cesarean delivery. METHODS:Between January 1, 1999, and December 31, 2000, a prospective cohort study of all cesarean deliveries was conducted at 13 university centers. Information regarding maternal and infant outcomes was abs...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,多中心研究

    doi:10.1097/01.AOG.0000237116.72011.f3

    authors: Alexander JM,Leveno KJ,Hauth J,Landon MB,Thom E,Spong CY,Varner MW,Moawad AH,Caritis SN,Harper M,Wapner RJ,Sorokin Y,Miodovnik M,O'Sullivan MJ,Sibai BM,Langer O,Gabbe SG,National Institute of Child Health and Human Deve

    更新日期:2006-10-01 00:00:00

  • A second-stage partogram.

    abstract:OBJECTIVE:To describe a second-stage partogram based on a system of scoring the descent and position of the fetal head and to use this system for studying progress in the second stage of labor and predicting mode of delivery and obstetric outcome. METHODS:A prospective observational study of 1413 women at term with a ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(00)00981-9

    authors: Sizer AR,Evans J,Bailey SM,Wiener J

    更新日期:2000-11-01 00:00:00

  • Body mass index and outcome of incontinence surgery.

    abstract:OBJECTIVE:To analyze the influence of body mass on the outcome of surgery for urinary incontinence. METHODS:Among 291 women operated on for stress incontinence, 187 (64%) were available for follow-up at 5 years. Eighty women had anterior colporrhaphy, 49 anterior colporrhaphy with needle suspension of the bladder neck...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(98)00513-4

    authors: Zivkovic F,Tamussino K,Pieber D,Haas J

    更新日期:1999-05-01 00:00:00

  • Sexually transmitted infection testing and screening in hospital-based primary care visits by women.

    abstract:OBJECTIVE:To explore determinants of sexually transmitted infection screening of asymptomatic women and sexually transmitted infection testing of women with genitourinary symptoms, to investigate the effect of specific genitourinary symptoms on sexually transmitted infection testing, and to examine trends in screening....

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/01.AOG.0000151129.47746.be

    authors: Huppert JS,Goodman E,Khoury J,Slap G

    更新日期:2005-02-01 00:00:00

  • Diagnosis and Treatment of Vulvar Dermatoses.

    abstract::Vulvar symptoms of pain, dyspareunia, and pruritus are common and may significantly affect a woman's sense of well-being and sexual function. Despite this, vulvar symptoms are often underreported by women. When identified, however, vulvovaginal symptoms should be addressed by health care providers to optimize care. Th...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,评审

    doi:10.1097/AOG.0000000000002460

    authors: Stockdale CK,Boardman L

    更新日期:2018-02-01 00:00:00

  • Typhoid fever in pregnancy.

    abstract::Fourteen cases of typhoid fever complicating pregnancy are presented. The diagnosis was confirmed by blood cultures in 13 patients and by a rising Widal titer in one. Stool cultures were positive in only two out of five patients; urine cultures in 12 patients and cervical cultures in five patients were all negative. T...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Seoud M,Saade G,Uwaydah M,Azoury R

    更新日期:1988-05-01 00:00:00

  • Evaluation of a continuous tissue pH monitor in the human fetus during labor.

    abstract::Continuous tissue pH monitoring of the fetus was successfully conducted in 13 of 21 patients (61.9%) during labor. There was a significant correlation between the tissue pH and both the scalp capillary blood pH (r = 0.94, P less than 0.001) and the umbilical artery blood pH (r = 0.92, P less than 0.01). These findings...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Kellner KR,Key TC,Cruz AC,Spellacy WN

    更新日期:1980-04-01 00:00:00

  • Clinical significance of urethral instability.

    abstract::Variations of urethral pressure were registered with microtransducers in 427 gynecologic patients with lower urinary tract symptoms during urethrocystometry. Urethral instability (variation of urethral pressure greater than 15 cm of water) was found in 16.4% of patients. The comparison of the urinary symptoms and the ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Weil A,Miège B,Rottenberg R,Krauer F

    更新日期:1986-07-01 00:00:00

  • Clinical application of fetal weight determination by real-time ultrasound measurements.

    abstract::The weights of 101 neonates delivered within 72 hours of real-time ultrasound examination were compared with the weight calculated from the ultrasonically measured biparietal diameter and abdominal circumference. A high degree of correlation (4 = .9624) was found between actual and calculated weights. This method of w...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Ott WJ

    更新日期:1981-06-01 00:00:00

  • Evaluation of preterm delivery in a systemic lupus erythematosus pregnancy clinic.

    abstract:OBJECTIVE:To identify the primary etiology of preterm birth in women with systemic lupus erythematosus, analyzing prospective data collected on 66 pregnancies in 58 women followed-up at a lupus pregnancy center. METHODS:Hospital records were reviewed and subjects were interviewed for pregnancies delivered after 23 com...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/0029-7844(95)00186-U

    authors: Johnson MJ,Petri M,Witter FR,Repke JT

    更新日期:1995-09-01 00:00:00

  • Immunologic thrombocytopenic purpura and pregnancy: six new cases.

    abstract::Six new cases of idiopathic thrombocytopenic purpura (ITP) associated with pregnancy are reported; one of these patients delivered triplets. In addition, 78 patients with 122 pregnancies and 124 fetuses have been reported previously. The maternal mortality rate was 4% and the fetal mortality rate was 18%. Prior recomm...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/00006250-197805000-00018

    authors: O'Reilly RA,Taber BZ

    更新日期:1978-05-01 00:00:00

  • A trial of prophylactic cefamandole in extended gynecologic surgery.

    abstract::A double-blind randomized trial of antibiotic prophylaxis was performed with 49 patients undergoing extended pelvic surgery for adenocarcinoma of the endometrium. In this series infections of the Hemovac drain site(s) were most common (8 of 10 infections); only 1 serious infection, pelvic cellulitis, occurred. Short-t...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Creasman WT,Hill GB,Weed JC Jr,Gall SA

    更新日期:1982-03-01 00:00:00